Ibuprofen
- Product NDC
- 85534-0011
- 11-digit product format
- 855340011
- Labeler code
- 85534
- Product ID
- 85534-0011_55221d60-54df-9469-e063-6294a90a2f91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- HAWAII REPACK, INC.
- Application
- ANDA213794
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- Substance
- IBUPROFEN
- Active strength
- 400 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213794-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | |
| A213794-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | |
| A213794-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213794-001 | AB |
| A213794-002 | AB |
| A213794-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213794-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213794-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213794-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213794-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213794-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213794-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 400 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WK2XYI10QM | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6239818c-747d-4cbb-9b41-27ca8bbce41b | Available on FDA.report |
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 | REMEDYREPACK INC. | 2144eff0-d7ab-486d-b116-a4ff3ae2afe2 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | St. Mary's Medical Park Pharmacy | 0a98cce4-f5c0-12a8-e063-6294a90a4e7e | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 34a9b94f-93ba-4a7c-92eb-d0b4b530d887 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | HAWAII REPACK, INC. | 6239818c-747d-4cbb-9b41-27ca8bbce41b | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 85534-0011 |
| Ibuprofen | IBUPROFEN | Sportpharm LLC | cef04ae4-e78a-454d-bb66-84b1d348c106 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Unit Dose Solutions, Inc. | 5515e80f-7513-b425-e063-6294a90aa542 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 2fa4bfc8-386c-433b-bc46-24fc8ec1bca1 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | ec6b2df4-2f4f-4601-8b53-0542664e0bd9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | bdc3f482-6fba-4420-9118-0f5cb7744e97 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 13fd4401-1821-4f2b-a44e-96aa2fa75b5c | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 25d9f5fc-4d95-4018-add8-ba696b6079b2 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 05ce8e8e-0b25-061e-e063-6394a90a2e92 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Coupler LLC | 50766a3d-1a22-be14-e063-6294a90a0ed2 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | NorthStar Rx LLC | aeee629b-255c-40d8-8e95-779aec00f723 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Direct_Rx | 1aa11b52-1aca-9219-e063-6294a90a470f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | f24582be-8d70-4848-bd54-e55fa28f394f | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | e5db46f3-043b-40ac-a89b-c90bd562e7b4 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 3db0c659-cc43-45dc-8442-bc89093d94d7 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | f60445d3-807e-0bbf-e053-2995a90a1299 | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 8d5f7d2a-af48-4d47-8bf5-48f01c092d24 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85534-0011-0 | 85534001100 | 30 TABLET in 1 BOTTLE (85534-0011-0) | 30 tablet | 2025-06-25 | No | No | Current |
| 85534-0011-1 | 85534001101 | 60 TABLET in 1 BOTTLE (85534-0011-1) | 60 tablet | 2025-06-25 | No | No | Current |
| 85534-0011-2 | 85534001102 | 90 TABLET in 1 BOTTLE (85534-0011-2) | 90 tablet | 2025-06-25 | No | No | Current |
| 85534-0011-3 | 85534001103 | 120 TABLET in 1 BOTTLE (85534-0011-3) | 120 tablet | 2025-06-25 | No | No | Current |