| NDC Code | 43386-357-10 |
|---|
| Package Description | 1000 TABLET in 1 BOTTLE (43386-357-10) |
|---|
| Product NDC | 43386-357 |
|---|
| 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 | 20161201 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA206245 |
|---|
| Manufacturer | Lupin Pharmaceuticals,Inc. |
|---|
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
|---|
| Strength | 325; 7.5 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|