NDC properties for "timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution" (RxCUI 1992303)
About this data
The tables show NDC propoerties for timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution with the RxCUI 1992303
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product
Details for timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution (RxCUI 1992303)
| ANDA | ANDA074262 |
|---|---|
| ANDA | ANDA074466 |
| ANDA | ANDA074747 |
| ANDA | ANDA077259 |
| ANDA | ANDA078771 |
| ANDA | ANDA217343 |
| ANDA | ANDA217764 |
| ANDA | ANDA218460 |
| MMSL_CODE | BD3330 |
| MMSL_CODE | CD3330 |
| MMSL_CODE | MTH_RXN_BD3330 |
| RxCUI | 1992303 |
| SNOMEDCT | 330721008 |
| SPL_SET_ID | 140e1bfc-b75e-40d1-856c-242be4d9c8cc |
| SPL_SET_ID | 15732de7-64b9-4c42-897d-89ae1b330192 |
| SPL_SET_ID | 1ffd9ed1-8ab4-4036-bbc6-dcf58e659248 |
| SPL_SET_ID | 2ed21930-1e05-46de-8acd-cb6f4798a7fa |
| SPL_SET_ID | 3ec1cc3c-1de1-4df3-8443-7b5a8cb21f85 |
| SPL_SET_ID | 42887224-997c-4f08-8e2c-918de7195a6e |
| SPL_SET_ID | 4847f180-45e6-40f0-ae8c-6cc500cb0add |
| SPL_SET_ID | 5305a38e-d9c8-4f9e-bf67-b246abc82cb1 |
| SPL_SET_ID | 545b7bee-8d5d-4206-b973-8de3c14d6dfe |
| SPL_SET_ID | 5d60db57-ca24-4cab-a90d-8cf06992a34e |
| SPL_SET_ID | 64561dfd-3704-4820-aef6-d0d26cef7255 |
| SPL_SET_ID | 6c9f3971-8c07-4d3a-915d-76438baa2a0b |
| SPL_SET_ID | 85724f95-6fc9-4f0c-b69d-05a23b093e2b |
| SPL_SET_ID | 9c14ca2d-80f3-48ef-b99a-beafaa728a24 |
| SPL_SET_ID | 9db7322d-eb31-4fff-9b14-8a0294d01704 |
| SPL_SET_ID | 9fd81371-caca-44c3-bd1d-d095b26a0241 |
| SPL_SET_ID | b41b1b81-5d8c-48a9-e053-2a95a90a6ef6 |
| SPL_SET_ID | c9726422-f794-4d39-a437-17dcb8c0f3b5 |
| SPL_SET_ID | d6fa2971-dacf-42ab-99bc-c7ce6013221e |
| SPL_SET_ID | e16c33fd-aa86-49ad-a767-c79ade4a62c7 |
| SPL_SET_ID | f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea |
| VUID | 4002852 |
| VUID | 4014943 |
| Prescribable Synonym | timolol 0.5 % 12HR Ophthalmic Solution |
| RXNAV_STR | 12 HR timolol 5 MG/ML Ophthalmic Solution |
| RxNorm Name | 12 HR timolol 5 MG/ML Ophthalmic Solution |
| RxNorm Synonym | timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution |
| RxNorm Synonym | timolol 0.5 % 12 HR Ophthalmic Solution |
| Related queries | Interactions (for RxCUI 1992303) |
NDC Properties
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 16571014110
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-10 |
| NDC Item | 16571014110 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-10) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014115
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-15 |
| NDC Item | 16571014115 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 16571014150
| NDC 9 | 16571-141 |
|---|---|
| NDC 10 | 16571-141-50 |
| NDC Item | 16571014150 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-141-50) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 16571-141 |
NDC Item 17478028810
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-10 |
| NDC Item | 17478028810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028811
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-11 |
| NDC Item | 17478028811 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 17478028812
| NDC 9 | 17478-288 |
|---|---|
| NDC 10 | 17478-288-12 |
| NDC Item | 17478028812 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074466 |
| FDA SPL set id | 639625 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-288 |
NDC Item 42571040421
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-21 |
| NDC Item | 42571040421 |
| Packaging | 5 mL in 1 BOTTLE (42571-404-21) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 42571040488
| NDC 9 | 42571-404 |
|---|---|
| NDC 10 | 42571-404-88 |
| NDC Item | 42571040488 |
| Packaging | 10 mL in 1 BOTTLE (42571-404-88) |
| ANDA | ANDA217343 |
| FDA SPL set id | 813651 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-404 |
NDC Item 50090185200
| NDC 9 | 50090-1852 |
|---|---|
| NDC 10 | 50090-1852-0 |
| NDC Item | 50090185200 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-1852-0) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 717511 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-1852 |
NDC Item 50090344100
| NDC 9 | 50090-3441 |
|---|---|
| NDC 10 | 50090-3441-0 |
| NDC Item | 50090344100 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) |
| ANDA | ANDA074262 |
| FDA SPL set id | 844230 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-3441 |
NDC Item 50090509100
| NDC 9 | 50090-5091 |
|---|---|
| NDC 10 | 50090-5091-0 |
| NDC Item | 50090509100 |
| Packaging | 1 BOTTLE in 1 CARTON (50090-5091-0) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 501115 |
| Labeler | A-S Medication Solutions LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5091 |
NDC Item 50090576900
| NDC 9 | 50090-5769 |
|---|---|
| NDC 10 | 50090-5769-0 |
| NDC Item | 50090576900 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 789204 |
| Labeler | A-S Medication Solutions |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50090-5769 |
NDC Item 55545100101
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-1 |
| NDC Item | 55545100101 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100102
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-2 |
| NDC Item | 55545100102 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 55545100103
| NDC 9 | 55545-1001 |
|---|---|
| NDC 10 | 55545-1001-3 |
| NDC Item | 55545100103 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1001-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281769 |
| Labeler | FDC Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55545-1001 |
NDC Item 60758080105
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-05 |
| NDC Item | 60758080105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 60758080110
| NDC 9 | 60758-801 |
|---|---|
| NDC 10 | 60758-801-10 |
| NDC Item | 60758080110 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074747 |
| COLORTEXT | white(clear/ light yellow) |
| Color | C48325 __ |
| FDA SPL set id | 600609 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1997-05-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60758-801 |
NDC Item 61314022705
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-05 |
| NDC Item | 61314022705 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022710
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-10 |
| NDC Item | 61314022710 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 61314022715
| NDC 9 | 61314-227 |
|---|---|
| NDC 10 | 61314-227-15 |
| NDC Item | 61314022715 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-227-15) |
| ANDA | ANDA074262 |
| FDA SPL set id | 804173 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1996-01-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 61314-227 |
NDC Item 64980051401
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-01 |
| NDC Item | 64980051401 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051405
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-05 |
| NDC Item | 64980051405 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 64980051415
| NDC 9 | 64980-514 |
|---|---|
| NDC 10 | 64980-514-15 |
| NDC Item | 64980051415 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-514-15) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| FDA SPL set id | 804336 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 64980-514 |
NDC Item 65145015201
| NDC 9 | 65145-152 |
|---|---|
| NDC 10 | 65145-152-01 |
| NDC Item | 65145015201 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-152 |
NDC Item 65145015301
| NDC 9 | 65145-153 |
|---|---|
| NDC 10 | 65145-153-01 |
| NDC Item | 65145015301 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-153 |
NDC Item 65145015401
| NDC 9 | 65145-154 |
|---|---|
| NDC 10 | 65145-154-01 |
| NDC Item | 65145015401 |
| Packaging | 1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA218460 |
| FDA SPL set id | 809977 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-09-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65145-154 |
NDC Item 68682081305
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-05 |
| NDC Item | 68682081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 68682081310
| NDC 9 | 68682-813 |
|---|---|
| NDC 10 | 68682-813-10 |
| NDC Item | 68682081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 657377 |
| Labeler | Oceanside Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 68682-813 |
NDC Item 69315032505
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-05 |
| NDC Item | 69315032505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032510
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-10 |
| NDC Item | 69315032510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 69315032515
| NDC 9 | 69315-325 |
|---|---|
| NDC 10 | 69315-325-15 |
| NDC Item | 69315032515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (69315-325-15) |
| ANDA | ANDA218460 |
| COLORTEXT | yellow(colorless to light yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 828008 |
| Labeler | Leading Pharma, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-11-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69315-325 |
NDC Item 70069070601
| NDC 9 | 70069-706 |
|---|---|
| NDC 10 | 70069-706-01 |
| NDC Item | 70069070601 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-706-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-706 |
NDC Item 70069070701
| NDC 9 | 70069-707 |
|---|---|
| NDC 10 | 70069-707-01 |
| NDC Item | 70069070701 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-707-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-707 |
NDC Item 70069070801
| NDC 9 | 70069-708 |
|---|---|
| NDC 10 | 70069-708-01 |
| NDC Item | 70069070801 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-708-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217764 |
| FDA SPL set id | 795204 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-708 |
NDC Item 70756065615
| NDC 9 | 70756-656 |
|---|---|
| NDC 10 | 70756-656-15 |
| NDC Item | 70756065615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-656-15) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-656 |
NDC Item 70756065730
| NDC 9 | 70756-657 |
|---|---|
| NDC 10 | 70756-657-30 |
| NDC Item | 70756065730 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 717503 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-657 |
NDC Item 72603054001
| NDC 9 | 72603-540 |
|---|---|
| NDC 10 | 72603-540-01 |
| NDC Item | 72603054001 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 835679 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-12-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-540 |
NDC Item 76519116300
| NDC 9 | 76519-1163 |
|---|---|
| NDC 10 | 76519-1163-0 |
| NDC Item | 76519116300 |
| Packaging | 5 mL in 1 BOTTLE (76519-1163-0) |
| ANDA | ANDA077259 |
| Labeler | H.J. Harkins Co, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76519-1163 |
NDC Item 81469021005
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-05 |
| NDC Item | 81469021005 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 81469021010
| NDC 9 | 81469-210 |
|---|---|
| NDC 10 | 81469-210-10 |
| NDC Item | 81469021010 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA078771 |
| FDA SPL set id | 785224 |
| Labeler | First Nation Group, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 81469-210 |
NDC Item 82260081305
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-05 |
| NDC Item | 82260081305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |
NDC Item 82260081310
| NDC 9 | 82260-813 |
|---|---|
| NDC 10 | 82260-813-10 |
| NDC Item | 82260081310 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 863431 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2020-06-01 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA018086 |
| Related queries | Properties for NDC 9 82260-813 |