Application 076642
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 7.5MG;200MG | No | Yes |
| 002 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 5MG;200MG | No | No |
| 003 | REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 2.5MG;200MG | No | No |
| 004 | REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 10MG;200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 |
| A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | ||
| A076642-003 | REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | ||
| A076642-004 | REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | 10MG;200MG | TABLET / ORAL | 2007-10-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076642-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | AB | 2004-03-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | AB | 2004-03-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076642-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076642-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076642-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076642-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076642-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076642-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076642-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076642-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076642-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076642-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076642-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076642-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076642-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076642-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076642-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076642-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076642-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076642-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076642-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076642-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076642-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076642-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076642-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076642-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076642-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076642-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076642-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076642-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076642-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076642-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076642-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076642-001 | AB | 1 | 5aa47cf7b7d7… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Ibuprofen | HYDROCODONE BITARTRATE AND IBUPROFEN | Amneal Pharmaceuticals of New York LLC | abc33718-4e88-43ea-9ffa-2b04ffc812ef | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | 076642 ANDA076642 53746-117 53746-145 53746-146 53746-116 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-268 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Rebel Distributors Corp | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-116 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-117 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-145 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-146 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 63629-5437 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Bryant Ranch Prepack | ANDA | Current |
| 63629-5437 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Bryant Ranch Prepack | ANDA | Current |
| 63739-557 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | McKesson Packaging Services a business unit of McKesson Corporation | ANDA | Current |
| 68084-841 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | American Health Packaging | ANDA | Current |
| 68084-841 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | American Health Packaging | ANDA | Current |
| 68084-841 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | American Health Packaging | ANDA | Current |
| 68084-841 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | American Health Packaging | ANDA | Current |
| 71335-0104 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Bryant Ranch Prepack | ANDA | Current |
| 71335-0104 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Bryant Ranch Prepack | ANDA | Current |
| 71335-0104 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Bryant Ranch Prepack | ANDA | Current |