| NDC Code | 0054-3000-01 |
| Package Description | 100 CAPSULE in 1 BOTTLE (0054-3000-01) |
| Product NDC | 0054-3000 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Butalbital, Acetaminophen, Caffeine And Codeine Phosphate |
| Non-Proprietary Name | Butalbital, Acetaminophen, Caffeine And Codeine Phosphate |
| Dosage Form | CAPSULE |
| Usage | ORAL |
| Start Marketing Date | 20220509 |
| Marketing Category Name | ANDA |
| Application Number | ANDA215138 |
| Manufacturer | Hikma Pharmaceuticals USA Inc. |
| Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
| Strength | 325; 50; 40; 30 |
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
| Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS] |
| DEA Schedule | CIII |