Ibuprofen
- Product NDC
- 80425-0537
- 11-digit product format
- 804250537
- Labeler code
- 80425
- Product ID
- 80425-0537_3b9fdc58-687a-4e47-e063-6294a90a0189
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2025-08-05
- 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 |
|---|
| 80425-0537-1 | 80425053701 | 30 TABLET in 1 BOTTLE (80425-0537-1) | 30 tablet | 2025-08-05 | No | No | Historical |
| 80425-0537-2 | 80425053702 | 60 TABLET in 1 BOTTLE (80425-0537-2) | 60 tablet | 2025-08-05 | No | No | Historical |
| 80425-0537-3 | 80425053703 | 90 TABLET in 1 BOTTLE (80425-0537-3) | 90 tablet | 2025-08-05 | No | No | Historical |
| 80425-0537-4 | 80425053704 | 100 TABLET in 1 BOTTLE (80425-0537-4) | 100 tablet | 2025-08-05 | No | No | Historical |
| 80425-0537-5 | 80425053705 | 120 TABLET in 1 BOTTLE (80425-0537-5) | 120 tablet | 2025-08-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen Tablets, USP | Advanced Rx of Tennessee, LLC | 2025-08-05 | HUMAN PRESCRIPTION DRUG LABEL | 1 |