NDC properties for "timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel" (RxCUI 313408)
About this data
The tables show NDC propoerties for timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel with the RxCUI 313408
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product
Details for timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel (RxCUI 313408)
| ANDA | ANDA210640 |
|---|---|
| ANDA | ANDA212942 |
| ANDA | ANDA213540 |
| ANDA | ANDA214645 |
| ANDA | ANDA215733 |
| ANDA | ANDA216343 |
| MMSL_CODE | BD3328 |
| MMSL_CODE | CD3328 |
| NDA | NDA020330 |
| NDA | NDA020963 |
| RxCUI | 313408 |
| SNOMEDCT | 766409001 |
| SPL_SET_ID | 1f886442-2781-4be4-b20d-d22c2c209790 |
| SPL_SET_ID | 474b38a7-1b1e-424c-8dfd-9a9bd5284bc6 |
| SPL_SET_ID | 581f80f7-4419-49e2-867d-40443c75409f |
| SPL_SET_ID | 72b0d0ec-832a-4c25-b845-2537ab506354 |
| SPL_SET_ID | 75b3b776-5eb8-4381-ade1-5cf0e942d5ed |
| SPL_SET_ID | 79730e4f-d533-42c7-b7b6-cdbc47242baa |
| SPL_SET_ID | 9515f95c-e29b-3c7f-0bdd-cda783988a72 |
| SPL_SET_ID | ae373e96-9c96-412a-9c1d-e247b5feab5e |
| SPL_SET_ID | b909ecf0-c90a-4719-a144-9e74f457cb87 |
| SPL_SET_ID | d987fdfa-3643-aa1d-cacd-c4f95f192ce7 |
| SPL_SET_ID | e6c74f66-ee84-4bcc-b1da-b8e6ff240dd2 |
| SPL_SET_ID | e797f7c7-0588-4627-b060-8df6bcfe3f7b |
| SPL_SET_ID | e93036c6-3120-e989-e053-2a95a90acf7f |
| VUID | 4002854 |
| Prescribable Synonym | timolol maleate 0.5 % Ophthalmic Gel Forming Solution |
| RXNAV_STR | timolol 0.005 MG/MG Ophthalmic Gel |
| RxNorm Name | timolol 0.005 MG/MG Ophthalmic Gel |
| RxNorm Synonym | timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel |
| RxNorm Synonym | timolol 0.5 % Gel Forming Ophthalmic Solution |
| Related queries | Interactions (for RxCUI 313408) |
NDC Properties
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |
NDC Item 24208081905
| NDC 9 | 24208-819 |
|---|---|
| NDC 10 | 24208-819-05 |
| NDC Item | 24208081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 567541 |
| Labeler | Bausch & Lomb Incorporated |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 24208-819 |
NDC Item 43598074811
| NDC 9 | 43598-748 |
|---|---|
| NDC 10 | 43598-748-11 |
| NDC Item | 43598074811 |
| Packaging | 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 793699 |
| Labeler | Dr. Reddy's Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-748 |
NDC Item 59651031305
| NDC 9 | 59651-313 |
|---|---|
| NDC 10 | 59651-313-05 |
| NDC Item | 59651031305 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING |
| ANDA | ANDA213540 |
| FDA SPL set id | 786918 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-313 |
NDC Item 60219137603
| NDC 9 | 60219-1376 |
|---|---|
| NDC 10 | 60219-1376-3 |
| NDC Item | 60219137603 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-1376 |
NDC Item 60219205503
| NDC 9 | 60219-2055 |
|---|---|
| NDC 10 | 60219-2055-3 |
| NDC Item | 60219205503 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3) / 2.5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA216343 |
| FDA SPL set id | 801975 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2055 |
NDC Item 61314022505
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-05 |
| NDC Item | 61314022505 |
| Packaging | 5 mL in 1 BOTTLE (61314-225-05) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 61314022525
| NDC 9 | 61314-225 |
|---|---|
| NDC 10 | 61314-225-25 |
| NDC Item | 61314022525 |
| Packaging | 2.5 mL in 1 BOTTLE (61314-225-25) |
| FDA SPL set id | 790292 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 61314-225 |
NDC Item 62332054605
| NDC 9 | 62332-546 |
|---|---|
| NDC 10 | 62332-546-05 |
| NDC Item | 62332054605 |
| Packaging | 1 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE |
| ANDA | ANDA212942 |
| FDA SPL set id | 647002 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-11-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-546 |
NDC Item 68083045801
| NDC 9 | 68083-458 |
|---|---|
| NDC 10 | 68083-458-01 |
| NDC Item | 68083045801 |
| Packaging | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 695465 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-02-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-458 |
NDC Item 70069025101
| NDC 9 | 70069-251 |
|---|---|
| NDC 10 | 70069-251-01 |
| NDC Item | 70069025101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA210640 |
| COLORTEXT | WHITE(slightly viscous colorless solution) |
| Color | C48325 __ |
| FDA SPL set id | 827170 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-251 |
NDC Item 72162218502
| NDC 9 | 72162-2185 |
|---|---|
| NDC 10 | 72162-2185-2 |
| NDC Item | 72162218502 |
| Packaging | 5 mL in 1 BOTTLE (72162-2185-2) |
| FDA SPL set id | 800568 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 1998-12-24 |
| Marketing status | ACTIVE |
| NDA | NDA020963 |
| Related queries | Properties for NDC 9 72162-2185 |
NDC Item 72266020001
| NDC 9 | 72266-200 |
|---|---|
| NDC 10 | 72266-200-01 |
| NDC Item | 72266020001 |
| Packaging | 1 BOTTLE in 1 CARTON (72266-200-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA214645 |
| FDA SPL set id | 866357 |
| Labeler | FOSUN PHARMA USA INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-03-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72266-200 |
NDC Item 72603016301
| NDC 9 | 72603-163 |
|---|---|
| NDC 10 | 72603-163-01 |
| NDC Item | 72603016301 |
| Packaging | 1 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA215733 |
| FDA SPL set id | 747523 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-163 |
NDC Item 82260081905
| NDC 9 | 82260-819 |
|---|---|
| NDC 10 | 82260-819-05 |
| NDC Item | 82260081905 |
| Packaging | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING |
| FDA SPL set id | 867085 |
| Labeler | Bausch & Lomb Americas Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2018-02-14 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA020330 |
| Related queries | Properties for NDC 9 82260-819 |