Ibuprofen
- Product NDC
- 71335-1034
- 11-digit product format
- 713351034
- Labeler code
- 71335
- Product ID
- 71335-1034_c0d79aa4-9bcc-45ef-aa7e-7143b5c2c101
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2014-04-01
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- 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 | 71335-1034 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 71335-1034 | 71335-1034-1 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-2 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-3 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-4 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-5 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-6 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-7 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 71335-1034 | 71335-1034-8 | D | Discontinued by firm | 2026-10-16 |
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 | 71335-1034-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1034-7 | 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 | 71335-1034-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1034-7 | 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 | 71335-1034-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1034-7 | 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 | 71335-1034-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1034-7 | 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 | 71335-1034-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1034-7 | 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 | 71335-1034-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1034-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-1034-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-1034-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-1034-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-1034-8 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-1034-3 | 302b2466d912… | e7b80fea0513… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078329-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078329-001 | AB |
| A078329-002 | AB |
| A078329-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078329-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078329-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078329-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | AB | 1 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 31f59d10-d821-2291-e063-6294a90ac518 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3140a614-c7ae-3062-e063-6394a90ad3d7 | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | SOLA Pharmaceuticals, LLC | b19b8c34-e0c1-4982-92fc-34dbe7384935 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 1361b6d6-0443-460a-8446-41f63a1e28df | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 92efad86-31ae-78e5-e053-2995a90a0fda | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | a2160213-2a32-2044-e053-2995a90a21af | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8c3dccbb-1084-cd09-e053-2a95a90ac12a | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8cb93e5f-4ebc-24b7-e053-2a95a90a5a23 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 88795f0e-41b7-504e-e053-2995a90a3b9e | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals NY LLC | e07d989d-1b0e-4cc1-abf2-93c8b208a29a | 2023-12-30 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 7152b6ce-6113-4003-bf80-aa263be69392 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 400faee1-f662-470e-bcd6-7711dfaf9ba2 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 91723661-d0bb-4498-ac59-59bbdc334230 | 2022-01-27 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 8813a8a4-ebbd-4204-88a3-600a92ea9170 | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-1034-1 | 71335103401 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1034-1) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-2 | 71335103402 | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1034-2) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-3 | 71335103403 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1034-3) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-4 | 71335103404 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1034-4) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-5 | 71335103405 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1034-5) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-6 | 71335103406 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1034-6) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-7 | 71335103407 | 270 TABLET, FILM COATED in 1 BOTTLE (71335-1034-7) | 2018-11-27 | 0000-00-00 | No | No | Current |
| 71335-1034-8 | 71335103408 | 300 TABLET, FILM COATED in 1 BOTTLE (71335-1034-8) | 2018-11-27 | 0000-00-00 | No | No | Current |