Ibuprofen
- Product NDC
- 76420-577
- 11-digit product format
- 764200577
- Labeler code
- 76420
- Product ID
- 76420-577_0706e837-6b65-31c5-e063-6294a90a85e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| IBUPROFEN | 800 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
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 |
|---|
| 76420-577-01 | 76420057701 | 100 TABLET in 1 BOTTLE (76420-577-01) | 100 tablet | 2023-07-20 | No | No | Current |
| 76420-577-30 | 76420057730 | 30 TABLET in 1 BOTTLE (76420-577-30) | 30 tablet | 2023-07-20 | No | No | Current |
| 76420-577-60 | 76420057760 | 60 TABLET in 1 BOTTLE (76420-577-60) | 60 tablet | 2023-07-20 | No | No | Current |
| 76420-577-90 | 76420057790 | 90 TABLET in 1 BOTTLE (76420-577-90) | 90 tablet | 2023-07-20 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ibuprofen Tablets, USP Rx only | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-10-06 | HUMAN PRESCRIPTION DRUG LABEL | 2 |