"70518-3858-0" National Drug Code (NDC)

Butalbital, Acetaminophen And Caffeine 30 TABLET in 1 BLISTER PACK (70518-3858-0)
(REMEDYREPACK INC.)

NDC Code70518-3858-0
Package Description30 TABLET in 1 BLISTER PACK (70518-3858-0)
Product NDC70518-3858
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital, Acetaminophen And Caffeine
Non-Proprietary NameButalbital, Acetaminophen And Caffeine
Dosage FormTABLET
UsageORAL
Start Marketing Date20230911
Marketing Category NameANDA
Application NumberANDA040864
ManufacturerREMEDYREPACK 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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