Ibuprofen
- Product NDC
- 68788-7080
- 11-digit product format
- 687887080
- Labeler code
- 68788
- Product ID
- 68788-7080_006b3b91-3776-4eaa-8d03-26aeb4279017
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2018-01-11
- 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 | 68788-7080 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 68788-7080 | 68788-7080-1 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-2 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-3 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-5 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-6 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-7 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-8 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7080 | 68788-7080-9 | D | Discontinued by firm | 2026-10-15 |
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 | 68788-7080-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7080-6 | 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 | 68788-7080-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7080-6 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091625-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091625-001 | AB |
| A091625-002 | AB |
| A091625-003 | 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 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 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 | A091625-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091625-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091625-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091625-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091625-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091625-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091625-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091625-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091625-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-001 | 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 |
|---|---|---|---|---|---|
| 68788-7080-1 | EA - Each | 68788-7080 | c64fc1d7-eb71-4f44-8b6b-a5f04f6d2fd0 | 1 | 2020-04-20 |
| 68788-7080-2 | EA - Each | 68788-7080 | 30edc36e-51ae-4bc9-bfa4-0c0439baa1a3 | 1 | 2020-04-20 |
| 68788-7080-3 | EA - Each | 68788-7080 | 8595973c-495a-4c05-a712-50574ecdc31f | 1 | 2020-04-20 |
| 68788-7080-5 | EA - Each | 68788-7080 | 6fe31274-af37-4e4a-b78b-77d75d0cdd3d | 1 | 2020-04-20 |
| 68788-7080-6 | EA - Each | 68788-7080 | 81291014-3c7e-4a70-87be-deea33d42161 | 1 | 2020-04-20 |
| 68788-7080-7 | EA - Each | 68788-7080 | c9b0c867-dc5a-4174-b3df-d805b462df81 | 1 | 2020-04-20 |
| 68788-7080-8 | EA - Each | 68788-7080 | 63f1c805-c9da-4004-9e8a-ab715776fcdb | 1 | 2020-04-20 |
| 68788-7080-9 | EA - Each | 68788-7080 | c70ab419-45c8-472b-8665-1ccf8523dad9 | 1 | 2020-04-20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7080 | IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 7 | Legacy NDC | 20240526_a175df89-865e-47ab-9277-0f098cc1a24a.zip |
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 | Northwind Health Company, LLC | 2f12a20c-4293-d18a-e063-6294a90a3afc | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | f2a08223-a73a-5461-e053-2995a90a3bce | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | ab074ae8-5696-5327-e053-2a95a90a7ce3 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 894a5d14-e405-43ac-a5a2-0b4de5b28474 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | af9ac948-440c-5abf-e053-2995a90af2b5 | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Advanced Rx Pharmacy of Tennessee, LLC | c859cc7a-e13a-7df4-e053-2a95a90a47d6 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 60f1c099-5fb5-47e8-b228-11de1ef40f4b | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | ffc953f7-ed92-4528-bb2f-72c634c119fa | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | EXELAN PHARMACEUTICALS, INC. | 362f934a-4382-43bc-bedd-65081286f1c9 | 2024-03-19 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | fd691a4a-8010-45e6-b3da-b26374792f24 | 2024-01-26 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 8553e29a-7f6f-4ff8-9991-836e619c504d | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | e4644cb5-7fae-456a-98d3-62ba521cd0b2 | 2023-09-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PharmPak, Inc. | b493bf76-1e8b-4e72-bef6-aca4efc69cbe | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PharmPak, Inc. | 4d95bccd-8280-4d03-a574-927669c7cda0 | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PharmPak, Inc. | bb6d0547-c113-42f9-8bf2-c227a55ab758 | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | d2c7f045-e70c-4e2b-b2e0-d81a271d0a04 | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 2dc3108f-d917-40c6-865d-c900cf055d1c | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 444b2ea0-ec42-4bcf-b8d2-38b4b297ada0 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 4a86a190-da5d-4b7a-a05f-e3e7ccbfa603 | 2019-01-19 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7080-1 | 68788708001 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7080-1) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-2 | 68788708002 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-7080-2) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-3 | 68788708003 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7080-3) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-5 | 68788708005 | 50 TABLET, FILM COATED in 1 BOTTLE (68788-7080-5) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-6 | 68788708006 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7080-6) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-7 | 68788708007 | 21 TABLET, FILM COATED in 1 BOTTLE (68788-7080-7) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-8 | 68788708008 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-7080-8) | 2018-01-11 | 0000-00-00 | No | No | Current |
| 68788-7080-9 | 68788708009 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7080-9) | 2018-01-11 | 0000-00-00 | No | No | Current |