"70518-3491-0" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 POUCH in 1 BOX (70518-3491-0) / 1 TABLET in 1 POUCH (70518-3491-1)
(REMEDYREPACK INC.)

NDC Code70518-3491-0
Package Description100 POUCH in 1 BOX (70518-3491-0) / 1 TABLET in 1 POUCH (70518-3491-1)
Product NDC70518-3491
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20220822
Marketing Category NameANDA
Application NumberANDA209036
ManufacturerREMEDYREPACK INC.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength300; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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