"0603-3609-12" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 240 TABLET in 1 BOTTLE, PLASTIC (0603-3609-12)
(Qualitest Pharmaceuticals)

NDC Code0603-3609-12
Package Description240 TABLET in 1 BOTTLE, PLASTIC (0603-3609-12)
Product NDC0603-3609
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20160429
Marketing Category NameANDA
Application NumberANDA040355
ManufacturerQualitest Pharmaceuticals
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength10; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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