NDC Code | 64950-290-16 |
Package Description | 473 mL in 1 BOTTLE (64950-290-16) |
Product NDC | 64950-290 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Butalbital, Acetaminophen And Caffeine |
Non-Proprietary Name | Butalbital, Acetaminophen, And Caffeine |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20250701 |
Marketing Category Name | ANDA |
Application Number | ANDA040387 |
Manufacturer | Genus Lifesciences Inc. |
Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
Strength | 325; 50; 40 |
Strength Unit | mg/15mL; mg/15mL; mg/15mL |
Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS] |
DEA Schedule | CIII |