Ibuprofen
- Product NDC
- 67046-1606
- 11-digit product format
- 670461606
- Labeler code
- 67046
- Product ID
- 67046-1606_410fb6b5-90f5-e92a-e063-6394a90a8404
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2025-10-13
- 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 |
|---|
| 67046-1606-3 | 67046160603 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1606-3) | 2025-10-13 | No | No | Historical |