Ibuprofen
- Product NDC
- 71610-895
- 11-digit product format
- 716100895
- Labeler code
- 71610
- Product ID
- 71610-895_31f59302-eaf0-211b-e063-6294a90a08b0
- 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
- 2018-08-24
- 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 |
|---|
| 71610-895-60 | 71610089560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-895-60) | 2025-04-01 | No | No | Historical |
| 71610-895-70 | 71610089570 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-895-70) | 2025-04-01 | No | No | Historical |
| 71610-895-80 | 71610089580 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-895-80) | 2025-04-01 | No | No | Historical |
| 71610-895-92 | 71610089592 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-895-92) | 2025-04-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen tablets | Aphena Pharma Solutions - Tennessee, LLC | 2025-04-04 | HUMAN PRESCRIPTION DRUG LABEL | 1 |