NDC Code | 0121-0833-81 |
Package Description | 12 CARTON in 1 CASE (0121-0833-81) / 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE (0121-0833-04) |
Product NDC | 0121-0833 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Childrens Ibuprofen Oral Suspension |
Non-Proprietary Name | Ibuprofen |
Dosage Form | SUSPENSION |
Usage | ORAL |
Start Marketing Date | 20250507 |
Marketing Category Name | ANDA |
Application Number | ANDA214789 |
Manufacturer | PAI Holdings, LLC dba PAI Pharma |
Substance Name | IBUPROFEN |
Strength | 100 |
Strength Unit | mg/5mL |
Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |