"53746-118-05" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 500 TABLET in 1 BOTTLE (53746-118-05)
(Amneal Pharmaceuticals, LLC)

NDC Code53746-118-05
Package Description500 TABLET in 1 BOTTLE (53746-118-05)
Product NDC53746-118
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100218
Marketing Category NameANDA
Application NumberANDA040769
ManufacturerAmneal Pharmaceuticals, LLC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength750; 7.5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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