Ibuprofen
- Product NDC
- 76420-848
- 11-digit product format
- 764200848
- Labeler code
- 76420
- Product ID
- 76420-848_2195e546-9f39-0130-e063-6294a90ad9c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- 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 |
|---|
| 76420-848-01 | 76420084801 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-848-01) | 2024-09-08 | No | No | Historical |
| 76420-848-05 | 76420084805 | 500 TABLET, FILM COATED in 1 BOTTLE (76420-848-05) | 2024-09-08 | No | No | Historical |
| 76420-848-30 | 76420084830 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-848-30) | 2024-09-08 | No | No | Historical |
| 76420-848-60 | 76420084860 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-848-60) | 2024-09-08 | No | No | Historical |
| 76420-848-90 | 76420084890 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-848-90) | 2024-09-08 | No | No | Historical |