Ibuprofen
- Product NDC
- 71610-897
- 11-digit product format
- 716100897
- Labeler code
- 71610
- Product ID
- 71610-897_31f61683-40cd-7542-e063-6294a90acbc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA213794
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-897-53 | 71610089753 | 60 TABLET in 1 BOTTLE (71610-897-53) | 60 tablet | 2025-04-02 | No | No | Historical |
| 71610-897-60 | 71610089760 | 90 TABLET in 1 BOTTLE (71610-897-60) | 90 tablet | 2025-04-02 | No | No | Historical |
| 71610-897-70 | 71610089770 | 120 TABLET in 1 BOTTLE (71610-897-70) | 120 tablet | 2025-04-02 | No | No | Historical |
| 71610-897-80 | 71610089780 | 180 TABLET in 1 BOTTLE (71610-897-80) | 180 tablet | 2025-04-02 | No | No | Historical |
| 71610-897-92 | 71610089792 | 270 TABLET in 1 BOTTLE (71610-897-92) | 270 tablet | 2025-04-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen Tablets, USP Rx only | Aphena Pharma Solutions - Tennessee, LLC | 2025-04-04 | HUMAN PRESCRIPTION DRUG LABEL | 1 |