"53746-109-05" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 500 TABLET in 1 BOTTLE (53746-109-05)
(Amneal Pharmaceuticals of New York LLC)

NDC Code53746-109-05
Package Description500 TABLET in 1 BOTTLE (53746-109-05)
Product NDC53746-109
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100118
Marketing Category NameANDA
Application NumberANDA040736
ManufacturerAmneal Pharmaceuticals of New York LLC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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