"65162-115-11" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 1000 TABLET in 1 BOTTLE (65162-115-11)
(Amneal Pharmaceuticals LLC)

NDC Code65162-115-11
Package Description1000 TABLET in 1 BOTTLE (65162-115-11)
Product NDC65162-115
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20160630
Marketing Category NameANDA
Application NumberANDA040746
ManufacturerAmneal Pharmaceuticals LLC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 7.5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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