FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6 | 2026-09-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Amneal Pharmaceuticals LLC | c2917c3d-3499-48a0-ba53-120cb979195d | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Zydus Pharmaceuticals USA Inc. | 31f62a49-4c6d-4ce3-a0ca-d159562370b1 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Actavis Pharma, Inc. | 1cf11710-f966-4529-8e08-02175f588bca | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Zydus Pharmaceuticals USA Inc. | 28948c32-a598-4bb5-bdb5-efbd87214d98 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Upsher-Smith Laboratories, LLC | 08529687-26b2-41e5-b6fb-35b4c0d891fe | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Upsher-Smith Laboratories, LLC | c369e1c3-90c5-4768-9741-56c62253a2c4 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Zydus Lifesciences Limited | 245898e5-3a61-4d6a-8375-8b3a8b7364ac | 2025-06-04 | Name/manufacturer search | |
| Isotretinoin | ISOTRETINOIN | Zydus Lifesciences Limited | dae33df0-386c-4db5-9759-7096e770ed17 | 2024-11-30 | Name/manufacturer search | |
| Isotretinoin | ISOTRETINOIN | Mayne Pharma | 0114567b-3bac-490d-b9eb-03a6c5d90935 | 2024-06-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Sun Pharmaceutical Industries, Inc. | b44200ba-6672-4ea7-b151-7caec3f53c9c | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Amneal Pharmaceuticals NY LLC | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Mayne Pharma | 72867c88-070f-4608-bfef-cc5225ebce6d | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Mayne Pharma | ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Isotretinoin | ISOTRETINOIN | Upsher-Smith Laboratories, LLC | ff1edbb8-ac0e-4563-9c2a-94385ce055e3 | 2022-10-24 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Absorica LD | ISOTRETINOIN | Sun Pharmaceutical Industries, Inc. | 3ef0cff8-19c1-4441-b780-fca6c7ee1615 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Amnesteem | ISOTRETINOIN | Mylan Pharmaceuticals Inc. | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c | 2026-08-15 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Claravis | ISOTRETINOIN | Teva Pharmaceuticals USA, Inc. | a31fd109-d0fd-4ab9-ba98-a3d64333c18d | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| ZENATANE | ISOTRETINOIN | BluePoint Laboratories | 486d4a4b-0de5-431a-bef7-dae6b0e4fa20 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | 5b524a51-a16b-496e-b764-11c98c479c36 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | 27b3cf26-f22e-5b70-1c24-009933b7c6ee | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |