IBU
- Product NDC
- 71610-501
- 11-digit product format
- 716100501
- Labeler code
- 71610
- Product ID
- 71610-501_32ebbdd1-95af-465b-8d01-7382978517ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2008-11-20
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-501-60 | 71610050160 | 90 TABLET in 1 BOTTLE (71610-501-60) | 90 tablet | 2020-12-08 | No | No | Historical |
| 71610-501-80 | 71610050180 | 180 TABLET in 1 BOTTLE (71610-501-80) | 180 tablet | 2020-12-08 | No | No | Historical |
| 71610-501-92 | 71610050192 | 270 TABLET in 1 BOTTLE (71610-501-92) | 270 tablet | 2020-12-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| IBU ™ Tablets | Aphena Pharma Solutions - Tennessee, LLC | 2021-01-21 | HUMAN PRESCRIPTION DRUG LABEL | 1 |