Ibuprofen
- Product NDC
- 72789-382
- 11-digit product format
- 727890382
- Labeler code
- 72789
- Product ID
- 72789-382_40bb88fc-9f49-04fa-e063-6294a90a044c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-382-30 | 72789038230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-382-30) | 2024-02-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| IBUPROFEN Tablets, USP | PD-Rx Pharmaceuticals, Inc. | 2025-10-09 | HUMAN PRESCRIPTION DRUG LABEL | 11 |
| IBUPROFEN Tablets, USP | PD-Rx Pharmaceuticals, Inc. | 2024-11-07 | HUMAN PRESCRIPTION DRUG LABEL | 10 |