"12634-783-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE (12634-783-01)
(Apotheca Inc.)

NDC Code12634-783-01
Package Description100 TABLET in 1 BOTTLE (12634-783-01)
Product NDC12634-783
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20060502
Marketing Category NameANDA
Application NumberANDA081080
ManufacturerApotheca Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength7.5; 500
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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