"76420-802-12" National Drug Code (NDC)

Butalbital, Acetaminophen, Caffeine 12 TABLET in 1 BOTTLE (76420-802-12)
(Asclemed USA, Inc.)

NDC Code76420-802-12
Package Description12 TABLET in 1 BOTTLE (76420-802-12)
Product NDC76420-802
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital, Acetaminophen, Caffeine
Non-Proprietary NameButalbital, Acetaminophen, And Caffeine
Dosage FormTABLET
UsageORAL
Start Marketing Date20190305
Marketing Category NameANDA
Application NumberANDA209587
ManufacturerAsclemed USA, Inc.
Substance NameACETAMINOPHEN; BUTALBITAL; CAFFEINE
Strength325; 50; 40
Strength Unitmg/1; mg/1; mg/1
Pharmacy ClassesBarbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA ScheduleCIII

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