Application 081069
- Type
- ANDA
- Sponsor
- MIKART
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | CAPSULE;ORAL | 500MG;5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A081069-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | CAPSULE / ORAL | 1989-11-30 | e64feba35796… |
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 |