"76519-1011-8" National Drug Code (NDC)

Hydrocodone Bitartate And Acetaminophen 120 TABLET in 1 BOTTLE, PLASTIC (76519-1011-8)
(H.J. Harkins Company, Inc.)

NDC Code76519-1011-8
Package Description120 TABLET in 1 BOTTLE, PLASTIC (76519-1011-8)
Product NDC76519-1011
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate, Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20120517
Marketing Category NameANDA
Application NumberANDA040846
ManufacturerH.J. Harkins Company, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength2.5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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