| NDC Code | 13107-004-11 |
|---|
| Package Description | 10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11) |
|---|
| Product NDC | 13107-004 |
|---|
| 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 | 20160602 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA204575 |
|---|
| Manufacturer | Aurolife Pharma, LLC |
|---|
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
|---|
| Strength | 7.5; 200 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|