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 | ST. MARY'S MEDICAL PARK PHARMACY | 3d347b9b-1b5c-68c8-e063-6294a90aaa9b | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | a8b9e9fe-e1a5-4a77-9a1f-d30eb622168c | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 0cc8836b-f0af-42e0-bd77-53fd1dd1aca7 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | SpecGx LLC | d621b526-4d9a-48a9-9a3e-d29d6aea2f31 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 69ce724d-6440-4def-aea9-26ad284ac35c | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | SpecGx LLC | 73c1059b-0c7d-42ef-9827-f018858fc447 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 8e99994a-83b4-4b1f-9654-4ae373bf2c4d | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 5a7fb0e7-eb06-4332-a786-d0051afd1dd9 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 679b4f87-59df-48d4-a9e6-e78aaeab23ea | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | d3b7f2b3-28c4-4ba5-961f-48e838600be2 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 092f4694-98df-41bd-b37c-afbcda087e56 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | a3cbf0c1-b589-4e4a-b355-01bddb7e4955 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | f7b554ab-2996-4cf0-a498-01cd5ef5df4f | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 5431c1bf-469b-4944-a558-52d098c9b0f0 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | e5d6de20-c195-4b97-963a-2f3832e50b49 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6fae7c90-1d80-4eb8-bbb8-8f945884f5c6 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3bd8e7b1-e31c-4298-ba1e-eaf2a0954208 | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | a2e33ea3-941f-4810-b008-abbb109730a9 | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | f1a7d87c-866d-4c6d-b9fd-e809b0a21773 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Hydrocodone Bitartrate and Acetaminophen |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 1d63d261-bdd4-4951-b8aa-09561e5b19fc | 2026-03-25 | 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 |