Ibuprofen
- Product NDC
- 68210-4201
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA079129
- Marketing category
- ANDA
- Substance
- IBUPROFEN
- Current FDA listing
- Historical FDA.report record
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 68210-4201-2 | 1 BOTTLE in 1 CARTON (68210-4201-2) > 25 TABLET, FILM COATED in 1 BOTTLE | 2022-07-06 | No | Current |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|---|
| 202ab858-77b2-4ba0-8589-4ef4da7189d3 | Ibuprofen | Spirit Pharmaceuticals LLC | 2024-12-13 | HUMAN OTC DRUG LABEL | 5 |