ibuprofen
- Product NDC
- 68788-8183
- 11-digit product format
- 687888183
- Labeler code
- 68788
- Product ID
- 68788-8183_b6a670e1-9a98-4742-b73c-b61105a07f5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- 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 | 68788-8183 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 68788-8183 | 68788-8183-1 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-2 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-3 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-4 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-5 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-6 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-7 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-8 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 68788-8183 | 68788-8183-9 | 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 | 68788-8183-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8183-9 | 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 | 68788-8183-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-8183-9 | 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 | 68788-8183-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-8183-9 | 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 | 68788-8183-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-8183-9 | 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 | 68788-8183-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-8183-9 | 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 | 68788-8183-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-8183-9 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202413-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-004 | IBUPROFEN | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202413-001 | AB |
| A202413-002 | AB |
| A202413-003 | 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 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A202413-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A202413-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A202413-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-001 | AB | 1 | 79d66fd596c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8183-1 | EA - Each | 68788-8183 | 437d6c30-5463-4735-b45d-cc8b33d6a455 | 1 | 2022-07-06 |
| 68788-8183-2 | EA - Each | 68788-8183 | 71c79ac2-d4d7-48a2-9282-269f44ba29bf | 1 | 2022-07-06 |
| 68788-8183-3 | EA - Each | 68788-8183 | 01c63b47-58de-4dad-b6f7-2bd828a45530 | 1 | 2022-07-06 |
| 68788-8183-4 | EA - Each | 68788-8183 | 14b618ba-b8a3-4449-b9ca-56b2f3b5c0cf | 1 | 2022-07-06 |
| 68788-8183-5 | EA - Each | 68788-8183 | 155e70c3-5ad6-4313-8a34-3d0726461c7c | 1 | 2022-07-06 |
| 68788-8183-6 | EA - Each | 68788-8183 | 1c1c8d06-43e0-449e-865b-a86eace6ffbf | 1 | 2022-07-06 |
| 68788-8183-7 | EA - Each | 68788-8183 | 49314f3e-3ddf-4062-a3bf-201115c4e39d | 1 | 2022-07-06 |
| 68788-8183-8 | EA - Each | 68788-8183 | e5f0d54f-3aca-4080-b18f-36f19ee67057 | 1 | 2022-07-06 |
| 68788-8183-9 | EA - Each | 68788-8183 | 0e070542-83a1-48bb-ba6e-8314cd67e859 | 1 | 2022-07-06 |
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 | Redpharm Drug | 44f609dd-c868-493f-e063-6294a90a7138 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 71b5b2a2-397e-4dcb-b0c7-ef08df4337e0 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 47711610-6577-4805-a2ce-cf9b7cbfa812 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | 41351cc0-5ec6-2f4d-e063-6294a90a733a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Coupler LLC | 410f7320-4caa-8f88-e063-6394a90acf93 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | a85080d7-50b4-461b-9d77-d6fbab971c03 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | PHOENIX RX LLC | 3b17587e-b609-42a9-e063-6294a90ab1f8 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | SOLA Pharmaceuticals, LLC | 44fb0842-c34e-477e-96df-350cd5d6800e | 2025-07-20 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 388e68dc-1822-f375-e063-6294a90a3d41 | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 2c3f8149-9b77-54cd-e063-6394a90a847e | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 3520deb7-5e45-3d0f-e063-6394a90ab44b | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 34673d3b-41cd-f4c9-e063-6394a90a8510 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3467b45b-c432-2923-e063-6394a90a1044 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Brisk Pharmaceuticals | 2dcbe4bb-fb24-e827-e063-6394a90acf9f | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 2d0c2d35-c212-4daa-b2c4-b407ca0b16ad | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 2b470e48-c23c-4f5c-916a-d38d8518896b | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | df0e55d0-617c-4084-984f-ece2f640e715 | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b0917020-f0ec-4d07-8fbf-c1eb909f466b | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b365be3a-91ad-46bf-a949-103c81f2359a | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Westminster Pharmaceuticals, LLC | eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-8183-1 | 68788818301 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8183-1) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-2 | 68788818302 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8183-2) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-3 | 68788818303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8183-3) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-4 | 68788818304 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-8183-4) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-5 | 68788818305 | 50 TABLET, FILM COATED in 1 BOTTLE (68788-8183-5) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-6 | 68788818306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8183-6) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-7 | 68788818307 | 21 TABLET, FILM COATED in 1 BOTTLE (68788-8183-7) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-8 | 68788818308 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8183-8) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 68788-8183-9 | 68788818309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8183-9) | 2022-04-29 | 0000-00-00 | No | No | Current |