"81005-123-01" National Drug Code (NDC)

Butalbital And Acetaminophen 100 TABLET in 1 BOTTLE (81005-123-01)
(Aarkish Pharmaceuticals NJ Inc.)

NDC Code81005-123-01
Package Description100 TABLET in 1 BOTTLE (81005-123-01)
Product NDC81005-123
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital And Acetaminophen
Non-Proprietary NameButalbital And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20230821
Marketing Category NameANDA
Application NumberANDA214955
ManufacturerAarkish Pharmaceuticals NJ Inc.
Substance NameACETAMINOPHEN; BUTALBITAL
Strength300; 50
Strength Unitmg/1; mg/1
Pharmacy ClassesBarbiturate [EPC], Barbiturates [CS]
DEA ScheduleCIII

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