Ibuprofen
- Product NDC
- 71335-1564
- 11-digit product format
- 713351564
- Labeler code
- 71335
- Product ID
- 71335-1564_aaae54aa-898d-4eaa-a8b5-d8b423c55ab9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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.
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 |
|---|---|---|---|---|---|---|---|
| 71335-1564-0 | 71335156400 | 84 TABLET, FILM COATED in 1 BOTTLE (71335-1564-0) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-1 | 71335156401 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1564-1) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-2 | 71335156402 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1564-2) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-3 | 71335156403 | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1564-3) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-4 | 71335156404 | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1564-4) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-5 | 71335156405 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1564-5) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-6 | 71335156406 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1564-6) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-7 | 71335156407 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1564-7) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-8 | 71335156408 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1564-8) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 71335-1564-9 | 71335156409 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1564-9) | 2015-12-21 | 0000-00-00 | No | No | Current |