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 |