"80425-0570-3" National Drug Code (NDC)

Butalbital, Acetaminophen, Caffeine 90 TABLET in 1 BOTTLE (80425-0570-3)
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0570-3
Package Description90 TABLET in 1 BOTTLE (80425-0570-3)
Product NDC80425-0570
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital, Acetaminophen, Caffeine
Non-Proprietary NameButalbital, Acetaminophen, And Caffeine
Dosage FormTABLET
UsageORAL
Start Marketing Date20260108
Marketing Category NameANDA
Application NumberANDA209587
ManufacturerAdvanced Rx of Tennessee, LLC
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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