"0904-6419-61" National Drug Code (NDC)

Hydrocodone Bitartate And Acetaminophen 100 TABLET in 1 BOX, UNIT-DOSE (0904-6419-61)
(Major Pharmaceuticals)

NDC Code0904-6419-61
Package Description100 TABLET in 1 BOX, UNIT-DOSE (0904-6419-61)
Product NDC0904-6419
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20150205
Marketing Category NameANDA
Application NumberANDA040099
ManufacturerMajor Pharmaceuticals
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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