| NDC Code | 0121-1022-00 |
|---|
| Package Description | 10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE |
|---|
| Product NDC | 0121-1022 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Dye Free Childrens Ibuprofen |
|---|
| Non-Proprietary Name | Ibuprofen |
|---|
| Dosage Form | SUSPENSION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20231103 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA210602 |
|---|
| 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] |
|---|