"55289-137-12" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 12 TABLET in 1 BOTTLE, PLASTIC (55289-137-12)
(PD-Rx Pharmaceuticals, Inc.)

NDC Code55289-137-12
Package Description12 TABLET in 1 BOTTLE, PLASTIC (55289-137-12)
Product NDC55289-137
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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