"55289-997-84" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 84 TABLET in 1 BOTTLE, PLASTIC (55289-997-84)
(PD-Rx Pharmaceuticals, Inc.)

NDC Code55289-997-84
Package Description84 TABLET in 1 BOTTLE, PLASTIC (55289-997-84)
Product NDC55289-997
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100118
Marketing Category NameANDA
Application NumberANDA040736
ManufacturerPD-Rx Pharmaceuticals, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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