Application 089971
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 500MG;5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | TABLET / ORAL | 1988-12-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089971-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;5MG | TABLET / ORAL | 1988-12-02 | cb3db0bc1861… |
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 | Bryant Ranch Prepack | 42a74abc-bdc7-4ea3-a185-029340111730 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 82b7fd34-02ac-434a-be38-a1f0ec4f3e50 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 9698729e-08d0-483c-b157-5a4061d97065 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6dde2f85-e329-4bca-832d-d45786df9f52 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8b132cf3-c138-59ae-e053-2995a90a98a2 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6ad80616-b38d-4569-b24a-aa86e39feb66 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 025eb0f7-d002-4ce0-87b8-71461ab18356 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 9bad45b7-32ce-47aa-bfdf-8e6a75513056 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8c2a7a68-5a84-c909-e053-2995a90ad5b6 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8592e901-9353-6fb6-e053-2a91aa0ad33b | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 86be8920-2f35-fbc3-e053-2991aa0a0015 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | c8d65aab-d6ae-bc69-e053-2a95a90a7b5e | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 48cc1378-ffab-4645-95bb-a05d78066575 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 26a2178e-e0e5-4d61-81fd-e30a3142f1f2 | 2024-02-02 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | b9f61b9c-d3f9-47e3-94a3-b5228f96f927 | 2023-09-25 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 62dd3c7a-4150-44a2-b05b-bc31308f2200 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 82b24978-8b15-43a9-b5b0-3313ed2a73c2 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | e6711f26-a01d-43e8-882a-d58561e4b67f | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 23dde6b8-3655-49ee-ac2c-28f80cf6b3c2 | 2022-07-20 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 5c00f98f-dcab-4bdb-901e-02eb873dea31 | 2022-05-10 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42254-100 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen | Rebel Distributors Corp | ANDA | Current |
| 66336-442 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen | Dispensing Solutions, Inc. | ANDA | Current |
| 67046-928 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0470 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | hydrocodone bitartrate and acetaminophen | RedPharm Drug Inc. | ANDA | Current |
| 75921-881 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen | Life Line Home Care Services, Inc. | ANDA | Current |