Ibuprofen
- Product NDC
- 71610-901
- 11-digit product format
- 716100901
- Labeler code
- 71610
- Product ID
- 71610-901_34675093-0bcb-d858-e063-6294a90a7198
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- Substance
- IBUPROFEN
- Active strength
- 800 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 |
|---|
| 71610-901-60 | 71610090160 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-901-60) | 2025-05-01 | No | No | Historical |
| 71610-901-70 | 71610090170 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-901-70) | 2025-05-01 | No | No | Historical |
| 71610-901-80 | 71610090180 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-901-80) | 2025-05-01 | No | No | Historical |
| 71610-901-92 | 71610090192 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-901-92) | 2025-05-01 | No | No | Historical |