| NDC Code | 42549-656-30 |
|---|
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (42549-656-30) |
|---|
| Product NDC | 42549-656 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20061106 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA077723 |
|---|
| Manufacturer | STAT Rx USA LLC |
|---|
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
|---|
| Strength | 7.5; 200 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
|---|
| DEA Schedule | CIII |
|---|