"0591-3369-01" National Drug Code (NDC)

Butalbital, Acetaminophen, And Caffeine 100 TABLET in 1 BOTTLE (0591-3369-01)
(Actavis Pharma, Inc.)

NDC Code0591-3369-01
Package Description100 TABLET in 1 BOTTLE (0591-3369-01)
Product NDC0591-3369
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital, Acetaminophen, And Caffeine
Non-Proprietary NameButalbital, Acetaminophen, And Caffeine
Dosage FormTABLET
UsageORAL
Start Marketing Date20071213
Marketing Category NameANDA
Application NumberANDA088616
ManufacturerActavis Pharma, 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]

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