Ibuprofen
- Product NDC
- 71610-902
- 11-digit product format
- 716100902
- Labeler code
- 71610
- Product ID
- 71610-902_3467c445-294a-2001-e063-6294a90aef55
- 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
- 600 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 |
|---|
| 71610-902-53 | 71610090253 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-902-53) | 2025-05-01 | No | No | Historical |
| 71610-902-60 | 71610090260 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-902-60) | 2025-05-01 | No | No | Historical |
| 71610-902-70 | 71610090270 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-902-70) | 2025-05-01 | No | No | Historical |
| 71610-902-80 | 71610090280 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-902-80) | 2025-05-01 | No | No | Historical |
| 71610-902-92 | 71610090292 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-902-92) | 2025-05-01 | No | No | Historical |