Ibuprofen
- Product NDC
- 76420-415
- 11-digit product format
- 764200415
- Labeler code
- 76420
- Product ID
- 76420-415_3b5c08ee-3c0c-616f-e063-6394a90a379a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- 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 |
|---|
| 76420-415-01 | 76420041501 | 100 TABLET in 1 BOTTLE (76420-415-01) | 100 tablet | 2025-08-02 | No | No | Historical |
| 76420-415-05 | 76420041505 | 500 TABLET in 1 BOTTLE (76420-415-05) | 500 tablet | 2025-08-02 | No | No | Historical |
| 76420-415-30 | 76420041530 | 30 TABLET in 1 BOTTLE (76420-415-30) | 30 tablet | 2025-08-02 | No | No | Historical |
| 76420-415-60 | 76420041560 | 60 TABLET in 1 BOTTLE (76420-415-60) | 60 tablet | 2025-08-02 | No | No | Historical |
| 76420-415-90 | 76420041590 | 90 TABLET in 1 BOTTLE (76420-415-90) | 90 tablet | 2025-08-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen Tablets, USP | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-08-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |