Ibuprofen
- Product NDC
- 53942-112
- 11-digit product format
- 539420112
- Labeler code
- 53942
- Product ID
- 53942-112_3a0d9cac-feac-139d-e063-6294a90a30c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Demoulas Super Markets, Inc
- Application
- ANDA202312
- Marketing category
- ANDA
- Marketing start
- 2025-07-16
- Substance
- IBUPROFEN
- Active strength
- 200 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 table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53942-112-03 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 2 |
| 53942-112-03 | Ibuprofen | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53942-112-03 | 53942011203 | 1 BOTTLE, PLASTIC in 1 CARTON (53942-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2025-07-16 | No | No | Current |