Application 090118
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | 2008-12-23 | ||
| A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | ||
| A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | 2008-12-23 |
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 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090118-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-12-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090118-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-12-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090118-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-12-23 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090118-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090118-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090118-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090118-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090118-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090118-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090118-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090118-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090118-003 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090118-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090118-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090118-003 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090118-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090118-002 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090118-003 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090118-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090118-002 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090118-003 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090118-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090118-002 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090118-003 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090118-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090118-002 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090118-003 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090118-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090118-002 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090118-003 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090118-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090118-002 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090118-003 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090118-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090118-002 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090118-003 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090118-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090118-002 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090118-003 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090118-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090118-002 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090118-003 | AA | 1 | ea99ee380514… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090118-001 | AA | 1 | 3f0d92c62455… |
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 Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | c29b97e9-8097-4d87-a420-ccf5aec8274a | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88c031ee-3d3d-4e8a-b69b-d18db612a9f3 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | AvPAK | 678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc3 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | 93b6dfdf-ba6e-4ea6-ab85-5ac121e33101 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | hydrocodone bitartrate and acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | 57e1fe79-eb60-4f4f-bb38-6df0270d408f | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Cranbury Pharmaceuticals, LLC | d4caec6d-4af2-4f1c-9add-c0c948b83b16 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma, LLC | 392a846e-7325-462d-b19b-8afda44c5cb0 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Redpharm Drug | 37451478-b961-873b-e063-6394a90a7b4e | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma, LLC | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | American Health Packaging | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | d1de0f93-1439-4ee3-b692-56e1a1400682 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Amneal Pharmaceuticals of New York LLC | e0cefc7b-e81c-4e15-89a0-fe71dc94338b | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Granules Pharmaceuticals Inc. | 136bbd47-7a54-493f-9158-a84d39221d6c | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | c4dc75b4-8016-4875-a859-6346c48cc0e7 | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 36bf5e37-9202-4288-8354-9d123fb692d3 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Elite Laboratories, Inc. | 89b8145f-5310-4b58-a65d-586dc90d642d | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Epic Pharma, LLC | 5179d4ab-6d57-4613-84fc-de3f6edd6a53 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Amneal Pharmaceuticals LLC | e23d135c-7aea-405a-804e-5c4f82179e96 | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 39b8382a-e96d-462d-895f-27cbb9a305ec | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
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 |
|---|---|---|---|---|---|
| 12634-260 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | hydrocodone bitartrate and acetaminophen | Apotheca Inc. | ANDA | Current |
| 21695-386 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Rebel Distributors Corp | ANDA | Current |
| 42254-214 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Rebel Distributors Corp | ANDA | Current |
| 42254-340 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Rebel Distributors Corp | ANDA | Current |
| 50090-1519 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | A-S Medication Solutions | ANDA | Current |
| 50090-2772 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2861 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-4067 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-4067 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-4072 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50436-3918 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Unit Dose Services | ANDA | Current |
| 50436-3918 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Unit Dose Services | ANDA | Current |
| 51655-900 | HYDROCODONE BITARTATE AND ACETAMINOPHEN | HYDROCODONE BITARTATE AND ACETAMINOPHEN | Northwind Pharmaceuticals | ANDA | Current |
| 51862-227 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 51862-228 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 51862-229 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 51862-585 | LORCET | Hydrocodone Bitartrate and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 51862-586 | LORCET PLUS | Hydrocodone Bitartrate and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 51862-587 | LORCET HD | Hydrocodone Bitartrate and Acetaminophen | Mayne Pharma Inc. | ANDA | Current |
| 57664-126 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-126 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-170 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-170 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-176 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-176 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 61919-452 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct Rx | ANDA | Current |
| 61919-452 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-452 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 64725-0026 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TYA Pharmaceuticals | ANDA | Current |
| 67296-1238 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1238 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | RedPharm Drug, Inc. | ANDA | Current |
| 71335-0063 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0063 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0063 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0385 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0385 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0385 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0385 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76086 | ORIG | 2023-11-02 |