"53002-6031-1" National Drug Code (NDC)

Butalbital, Acetaminophen, Caffeine 10 TABLET in 1 BOTTLE (53002-6031-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-6031-1
Package Description10 TABLET in 1 BOTTLE (53002-6031-1)
Product NDC53002-6031
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
ManufacturerRPK Pharmaceuticals, 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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