"42195-955-10" National Drug Code (NDC)

Butalbital, Acetaminophen And Caffeine 100 CAPSULE in 1 BOTTLE (42195-955-10)
(Xspire Pharma, LLC)

NDC Code42195-955-10
Package Description100 CAPSULE in 1 BOTTLE (42195-955-10)
Product NDC42195-955
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital, Acetaminophen And Caffeine
Non-Proprietary NameButalbital, Acetaminophen And Caffeine
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20170804
Marketing Category NameANDA
Application NumberANDA206615
ManufacturerXspire Pharma, LLC
Substance NameACETAMINOPHEN; BUTALBITAL; CAFFEINE
Strength300; 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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