Ibuprofen
- Product NDC
- 0904-7587
- 11-digit product format
- 009047587
- Labeler code
- 0904
- Product ID
- 0904-7587_4a1aa866-e39a-68e6-e063-6394a90a6432
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA071268
- Marketing category
- ANDA
- Marketing start
- 2025-11-03
- Substance
- IBUPROFEN
- Active strength
- 400 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7587-40 | Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 0904-7587-59 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM 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 |
|---|
| 0904-7587-40 | 00904758740 | 500 TABLET, FILM COATED in 1 BOTTLE (0904-7587-40) | 2025-11-03 | No | No | Historical |
| 0904-7587-59 | 00904758759 | 100 TABLET, FILM COATED in 1 BOTTLE (0904-7587-59) | 2025-11-03 | No | No | Historical |