"12634-616-04" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 120 mL in 1 BOTTLE (12634-616-04)
(Apotheca, Inc)

NDC Code12634-616-04
Package Description120 mL in 1 BOTTLE (12634-616-04)
Product NDC12634-616
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20140331
Marketing Category NameANDA
Application NumberANDA040838
ManufacturerApotheca, Inc
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength7.5; 325
Strength Unitmg/120mL; mg/120mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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