| NDC Code | 55289-997-60 |
|---|
| Package Description | 60 TABLET in 1 BOTTLE, PLASTIC (55289-997-60) |
|---|
| Product NDC | 55289-997 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20100118 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040736 |
|---|
| Manufacturer | PD-Rx Pharmaceuticals, Inc. |
|---|
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
|---|
| Strength | 5; 325 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|