Ibuprofen
- Product NDC
- 68788-4039
- 11-digit product format
- 687884039
- Labeler code
- 68788
- Product ID
- 68788-4039_a85080d7-50b4-461b-9d77-d6fbab971c03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2025-10-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4039-1 | 68788403901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-4039-1) | 2025-10-13 | No | No | Historical |
| 68788-4039-2 | 68788403902 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-4039-2) | 2025-10-13 | No | No | Historical |
| 68788-4039-3 | 68788403903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4039-3) | 2025-10-13 | No | No | Historical |
| 68788-4039-5 | 68788403905 | 50 TABLET, FILM COATED in 1 BOTTLE (68788-4039-5) | 2025-10-13 | No | No | Historical |
| 68788-4039-6 | 68788403906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4039-6) | 2025-10-13 | No | No | Historical |
| 68788-4039-8 | 68788403908 | 28 TABLET, FILM COATED in 1 BOTTLE (68788-4039-8) | 2025-10-13 | No | No | Historical |
| 68788-4039-9 | 68788403909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4039-9) | 2025-10-13 | No | No | Historical |