ibuprofen
- Product NDC
- 42507-057
- 11-digit product format
- 425070057
- Labeler code
- 42507
- Product ID
- 42507-057_0ac8ac5d-d10b-40f6-94f0-e85c8a557e58
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA075217
- Marketing category
- ANDA
- Marketing start
- 2000-09-03
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ibuprofen
- Brand name suffix
- infants
- Listing expiration
- 2027-12-31
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 |
|---|
| 42507-057-00 | ibuprofeninfants | 15 mL in 1 BOTTLE | SUSPENSION | 15 | | 6 |
| 42507-057-05 | ibuprofeninfants | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
| 42507-057-10 | ibuprofeninfants | 30 mL in 1 BOTTLE | SUSPENSION | 30 | | 6 |
| 42507-057-10 | ibuprofeninfants | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-057-00 | 42507005700 | 15 mL in 1 BOTTLE | 15 ml | | | | Historical |
| 42507-057-05 | 42507005705 | 1 BOTTLE in 1 CARTON (42507-057-05) / 15 mL in 1 BOTTLE (42507-057-00) | 1 bottle | 2000-09-03 | No | No | Current |
| 42507-057-10 | 42507005710 | 30 mL in 1 BOTTLE | 30 ml | | | | Historical |