Ibuprofen
- Product NDC
- 69367-394
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Substance
- IBUPROFEN
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 69367-394-01 | 100 TABLET, FILM COATED in 1 BOTTLE (69367-394-01) | 2024-05-23 | | No | Historical |
| 69367-394-05 | 500 TABLET, FILM COATED in 1 BOTTLE (69367-394-05) | 2024-05-23 | | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg | Redpharm Drug | 2025-12-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg | A-S Medication Solutions | 2025-11-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg | A-S Medication Solutions | 2025-11-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg | Preferred Pharmaceuticals Inc. | 2025-10-13 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg | Aphena Pharma Solutions - Tennessee, LLC | 2025-06-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg | Westminster Pharmaceuticals, LLC | 2024-10-10 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| Ibuprofen Tablets, USP 400 mg | Proficient Rx LP | 2024-10-02 | HUMAN PRESCRIPTION DRUG LABEL | 3 |
| Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-09-08 | HUMAN PRESCRIPTION DRUG LABEL | 1 |