Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63629-8887
- Requested package NDC
- 63629-8887-5
- 11-digit product format
- 636298887
- Labeler code
- 63629
- Product ID
- 63629-8887_d64ec11c-e7c3-4ab4-a293-f99c389a0d06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210211
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63629-8887 | 63629-8887-5 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | |
| A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | |
| A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210211-001 | AA |
| A210211-002 | AA |
| A210211-003 | AA |
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 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-10-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-10-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210211-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-10-30 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210211-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210211-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210211-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210211-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210211-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210211-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210211-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210211-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210211-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210211-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210211-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210211-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210211-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210211-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210211-001 | AA | 1 | 8072bd15b7f6… |
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 | 65c5abc7-520a-4267-acb6-ea6204a3ecfa | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 69ce724d-6440-4def-aea9-26ad284ac35c | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | f1a7d87c-866d-4c6d-b9fd-e809b0a21773 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 1d63d261-bdd4-4951-b8aa-09561e5b19fc | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 09db348f-8396-41b2-b639-608dcfdbccf4 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | db14e63a-8e3e-4524-b45a-cb09f705f73a | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | e5b559c3-4beb-4ba3-a10b-7a1ad1878a1e | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | c534f784-0e21-4891-8f7e-2dc327b267f1 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 66e184cd-fa32-431f-b843-9c4bea12593b | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Redpharm Drug | 46c13d54-b181-4da2-e063-6294a90ab5c5 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone/APAP | HYDROCODONE/APAP | Direct_Rx | 446e9f78-4034-5bb4-e063-6394a90ac739 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone/APAP | HYDROCODONE/APAP | Direct_Rx | 446f01f0-2853-d104-e063-6394a90ae351 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Eywa Pharma Inc | fcd2b59e-8087-475e-9e6b-911bd846ea96 | 2025-10-03 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | fed1eb12-3e39-1bf9-e053-6294a90afd77 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | American Health Packaging | 9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630 | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | d88e04c1-cd54-6a12-e053-2995a90a22b4 | 2024-12-24 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 2a485efe-a87c-4c55-9e17-7891b2fffb83 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 42a74abc-bdc7-4ea3-a185-029340111730 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | c8d65aab-d6ae-bc69-e053-2a95a90a7b5e | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | 210211 ANDA210211 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-8887-5 | 63629888705 | 60 TABLET in 1 BOTTLE (63629-8887-5) | 60 tablet | 2021-10-21 | 0000-00-00 | No | No | Current |