"76519-1081-1" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 10 TABLET in 1 BOTTLE (76519-1081-1)
(H.J. Harkins Company, Inc.)

NDC Code76519-1081-1
Package Description10 TABLET in 1 BOTTLE (76519-1081-1)
Product NDC76519-1081
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20160128
Marketing Category NameANDA
Application NumberANDA090415
ManufacturerH.J. Harkins Company, 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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