"55289-965-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE, PLASTIC (55289-965-01)
(PD-Rx Pharmaceuticals, Inc.)

NDC Code55289-965-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (55289-965-01)
Product NDC55289-965
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20070223
Marketing Category NameANDA
Application NumberANDA040813
ManufacturerPD-Rx Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength500; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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