"0406-0365-05" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 500 TABLET in 1 BOTTLE (0406-0365-05)
(SpecGx LLC)

NDC Code0406-0365-05
Package Description500 TABLET in 1 BOTTLE (0406-0365-05)
Product NDC0406-0365
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100422
End Marketing Date20180730
Marketing Category NameANDA
Application NumberANDA040409
ManufacturerSpecGx LLC
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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