NDC properties for "timolol 0.25 % Ophthalmic Solution" (RxCUI 1923428)
About this data
The tables show NDC propoerties for timolol 0.25 % Ophthalmic Solution with the RxCUI 1923428
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 0.25 % Ophthalmic Solution (RxCUI 1923428)
| ANDA | ANDA074261 |
|---|---|
| ANDA | ANDA074465 |
| ANDA | ANDA074746 |
| ANDA | ANDA077259 |
| ANDA | ANDA078771 |
| ANDA | ANDA217343 |
| ANDA | ANDA217764 |
| MMSL_CODE | BD3329 |
| MMSL_CODE | CD3329 |
| RxCUI | 1923428 |
| SNOMEDCT | 330720009 |
| SPL_SET_ID | 140e1bfc-b75e-40d1-856c-242be4d9c8cc |
| SPL_SET_ID | 15732de7-64b9-4c42-897d-89ae1b330192 |
| SPL_SET_ID | 2101d051-411e-466c-bba6-166a4615b17b |
| SPL_SET_ID | 2ed21930-1e05-46de-8acd-cb6f4798a7fa |
| SPL_SET_ID | 3ec1cc3c-1de1-4df3-8443-7b5a8cb21f85 |
| SPL_SET_ID | 545b7bee-8d5d-4206-b973-8de3c14d6dfe |
| SPL_SET_ID | 5d60db57-ca24-4cab-a90d-8cf06992a34e |
| SPL_SET_ID | 6c9f3971-8c07-4d3a-915d-76438baa2a0b |
| SPL_SET_ID | 9c14ca2d-80f3-48ef-b99a-beafaa728a24 |
| SPL_SET_ID | c9726422-f794-4d39-a437-17dcb8c0f3b5 |
| SPL_SET_ID | e16c33fd-aa86-49ad-a767-c79ade4a62c7 |
| SPL_SET_ID | f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea |
| VUID | 4002851 |
| VUID | 4026202 |
| Prescribable Synonym | timolol maleate 0.25 % Ophthalmic Solution |
| RXNAV_STR | timolol 2.5 MG/ML Ophthalmic Solution |
| RxNorm Name | timolol 2.5 MG/ML Ophthalmic Solution |
| RxNorm Synonym | timolol 0.25 % Ophthalmic Solution |
| RxNorm Synonym | timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution |
| Related queries | Interactions (for RxCUI 1923428) |
NDC Properties
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |
NDC Item 16571014010
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-10 |
| NDC Item | 16571014010 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-10) / 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 16571-140 |
NDC Item 16571014015
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-15 |
| NDC Item | 16571014015 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-15) / 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 16571-140 |
NDC Item 16571014050
| NDC 9 | 16571-140 |
|---|---|
| NDC 10 | 16571-140-50 |
| NDC Item | 16571014050 |
| Packaging | 1 BOTTLE in 1 CARTON (16571-140-50) / 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 16571-140 |
NDC Item 42571040321
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-21 |
| NDC Item | 42571040321 |
| Packaging | 5 mL in 1 BOTTLE (42571-403-21) |
| 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 42571-403 |
NDC Item 42571040388
| NDC 9 | 42571-403 |
|---|---|
| NDC 10 | 42571-403-88 |
| NDC Item | 42571040388 |
| Packaging | 10 mL in 1 BOTTLE (42571-403-88) |
| 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 42571-403 |
NDC Item 55545100001
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-1 |
| NDC Item | 55545100001 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-1) / 5 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100002
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-2 |
| NDC Item | 55545100002 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-2) / 10 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 55545100003
| NDC 9 | 55545-1000 |
|---|---|
| NDC 10 | 55545-1000-3 |
| NDC Item | 55545100003 |
| Packaging | 1 BOTTLE in 1 CARTON (55545-1000-3) / 15 mL in 1 BOTTLE |
| ANDA | ANDA077259 |
| APPROVED_DRUG_PRODUCT_MANUFACTURED_UNDER_CONTRACT | ANDA077259 |
| FDA SPL set id | 281715 |
| 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 55545-1000 |
NDC Item 60758080205
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-05 |
| NDC Item | 60758080205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 60758080210
| NDC 9 | 60758-802 |
|---|---|
| NDC 10 | 60758-802-10 |
| NDC Item | 60758080210 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA074746 |
| 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 60758-802 |
NDC Item 61314022605
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-05 |
| NDC Item | 61314022605 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022610
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-10 |
| NDC Item | 61314022610 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 61314022615
| NDC 9 | 61314-226 |
|---|---|
| NDC 10 | 61314-226-15 |
| NDC Item | 61314022615 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) |
| ANDA | ANDA074261 |
| 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 61314-226 |
NDC Item 64980051301
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-01 |
| NDC Item | 64980051301 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-01) / 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 64980-513 |
NDC Item 64980051305
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-05 |
| NDC Item | 64980051305 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-05) / 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 64980-513 |
NDC Item 64980051315
| NDC 9 | 64980-513 |
|---|---|
| NDC 10 | 64980-513-15 |
| NDC Item | 64980051315 |
| Packaging | 1 BOTTLE in 1 CARTON (64980-513-15) / 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 64980-513 |
NDC Item 68682081205
| NDC 9 | 68682-812 |
|---|---|
| NDC 10 | 68682-812-05 |
| NDC Item | 68682081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (68682-812-05) / 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 68682-812 |
NDC Item 70069070101
| NDC 9 | 70069-701 |
|---|---|
| NDC 10 | 70069-701-01 |
| NDC Item | 70069070101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-701-01) / 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 70069-701 |
NDC Item 70069070201
| NDC 9 | 70069-702 |
|---|---|
| NDC 10 | 70069-702-01 |
| NDC Item | 70069070201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-702-01) / 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 70069-702 |
NDC Item 70069070301
| NDC 9 | 70069-703 |
|---|---|
| NDC 10 | 70069-703-01 |
| NDC Item | 70069070301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-703-01) / 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 70069-703 |
NDC Item 70756065415
| NDC 9 | 70756-654 |
|---|---|
| NDC 10 | 70756-654-15 |
| NDC Item | 70756065415 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 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 70756-654 |
NDC Item 70756065530
| NDC 9 | 70756-655 |
|---|---|
| NDC 10 | 70756-655-30 |
| NDC Item | 70756065530 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 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 70756-655 |
NDC Item 81469020905
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-05 |
| NDC Item | 81469020905 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 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 81469-209 |
NDC Item 81469020910
| NDC 9 | 81469-209 |
|---|---|
| NDC 10 | 81469-209-10 |
| NDC Item | 81469020910 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 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 81469-209 |
NDC Item 82260081205
| NDC 9 | 82260-812 |
|---|---|
| NDC 10 | 82260-812-05 |
| NDC Item | 82260081205 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 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 82260-812 |