| NDC Code | 70010-054-01 |
| Package Description | 100 CAPSULE in 1 BOTTLE (70010-054-01) |
| Product NDC | 70010-054 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Butalbital And Acetaminophen |
| Non-Proprietary Name | Butalbital And Acetaminophen |
| Dosage Form | CAPSULE |
| Usage | ORAL |
| Start Marketing Date | 20200120 |
| Marketing Category Name | ANDA |
| Application Number | ANDA213115 |
| Manufacturer | Granules Pharmaceuticals Inc. |
| Substance Name | ACETAMINOPHEN; BUTALBITAL |
| Strength | 300; 50 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS] |
| DEA Schedule | CIII |