Hydrocodone Bitartrate and Ibuprofen
- Product NDC
- 71335-0104
- 11-digit product format
- 713350104
- Labeler code
- 71335
- Product ID
- 71335-0104_4e63cb6c-5d07-43b8-9228-83a1b79952c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076642
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 71335-0104 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 71335-0104 | 71335-0104-0 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-3 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-4 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-5 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-6 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-7 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-8 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0104 | 71335-0104-9 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0104-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0104-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0104-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0104-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0104-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0104-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0104-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0104-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0104-4 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 |
| A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | ||
| A076642-003 | REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | ||
| A076642-004 | REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | 10MG;200MG | TABLET / ORAL | 2007-10-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076642-001 | AB |
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 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | 2004-03-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | AB | 2004-03-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-001 | HYDROCODONE BITARTRATE AND IBUPROFEN | 7.5MG;200MG | TABLET / ORAL | AB | RS | 2004-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-002 | HYDROCODONE BITARTRATE AND IBUPROFEN | 5MG;200MG | TABLET / ORAL | AB | 2004-03-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-003 | REPREXAIN | 2.5MG;200MG | TABLET / ORAL | 2007-10-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-004 | REPREXAIN | 10MG;200MG | TABLET / ORAL | 2007-10-19 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076642-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076642-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076642-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076642-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076642-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076642-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076642-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076642-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076642-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076642-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076642-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076642-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076642-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076642-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076642-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076642-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076642-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076642-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076642-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076642-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076642-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076642-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076642-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076642-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076642-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076642-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076642-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076642-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076642-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076642-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076642-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076642-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076642-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076642-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076642-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076642-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076642-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076642-001 | AB | 1 | 5aa47cf7b7d7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ibuprofen | HYDROCODONE BITARTRATE AND IBUPROFEN | Amneal Pharmaceuticals of New York LLC | abc33718-4e88-43ea-9ffa-2b04ffc812ef | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | 076642 ANDA076642 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0104-0 | 71335010400 | 15 TABLET in 1 BOTTLE (71335-0104-0) | 15 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-1 | 71335010401 | 120 TABLET in 1 BOTTLE (71335-0104-1) | 120 tablet | 2018-10-10 | 0000-00-00 | No | No | Current |
| 71335-0104-2 | 71335010402 | 20 TABLET in 1 BOTTLE (71335-0104-2) | 20 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-3 | 71335010403 | 28 TABLET in 1 BOTTLE (71335-0104-3) | 28 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-4 | 71335010404 | 30 TABLET in 1 BOTTLE (71335-0104-4) | 30 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-5 | 71335010405 | 40 TABLET in 1 BOTTLE (71335-0104-5) | 40 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-6 | 71335010406 | 45 TABLET in 1 BOTTLE (71335-0104-6) | 45 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-7 | 71335010407 | 60 TABLET in 1 BOTTLE (71335-0104-7) | 60 tablet | 2018-09-14 | 0000-00-00 | No | No | Current |
| 71335-0104-8 | 71335010408 | 84 TABLET in 1 BOTTLE (71335-0104-8) | 84 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0104-9 | 71335010409 | 90 TABLET in 1 BOTTLE (71335-0104-9) | 90 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |