Ibuprofen
- Product NDC
- 71610-629
- 11-digit product format
- 716100629
- Labeler code
- 71610
- Product ID
- 71610-629_fb594a68-2160-4213-948a-02473c64c53c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2020-08-21
- 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 |
|---|
| 71610-629-60 | 71610062960 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-60) | 2021-12-17 | No | No | Historical |
| 71610-629-80 | 71610062980 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-80) | 2021-12-17 | No | No | Historical |
| 71610-629-92 | 71610062992 | 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-92) | 2022-01-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen tablets | Aphena Pharma Solutions - Tennessee, LLC | 2022-01-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |