ibuprofen
- Product NDC
- 0904-5463
- 11-digit product format
- 009045463
- Labeler code
- 0904
- Product ID
- 0904-5463_baccf3cf-e20d-468c-9b23-d39361a9a302
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075217
- Marketing category
- ANDA
- Marketing start
- 2000-01-08
- Substance
- IBUPROFEN
- Active strength
- 50 mg/1.25mL
- 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 | 50 mg/1.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 204442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5463-30 | ibuprofen | 30 mL in 1 BOTTLE | SUSPENSION | 30 | | 5 |
| 0904-5463-30 | ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 5 |
| 0904-5463-35 | ibuprofen | 15 mL in 1 BOTTLE | SUSPENSION | 15 | | 5 |
| 0904-5463-35 | ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5463 | IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250505_b4962985-47e6-4389-874f-76742b086e2f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-5463-30 | 00904546330 | 30 mL in 1 BOTTLE | 30 ml | | | | | Historical |
| 0904-5463-35 | 00904546335 | 1 BOTTLE in 1 CARTON (0904-5463-35) / 15 mL in 1 BOTTLE | 1 bottle | 2000-01-08 | 0000-00-00 | No | No | Current |