"43063-004-12" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 12 TABLET in 1 BOTTLE, PLASTIC (43063-004-12)
(PD-Rx Pharmaceuticals, Inc.)

NDC Code43063-004-12
Package Description12 TABLET in 1 BOTTLE, PLASTIC (43063-004-12)
Product NDC43063-004
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 NumberANDA040729
ManufacturerPD-Rx Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength500; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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