"12634-615-04" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 120 mL in 1 BOTTLE (12634-615-04)
(APOTHECA, INC)

NDC Code12634-615-04
Package Description120 mL in 1 BOTTLE (12634-615-04)
Product NDC12634-615
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20130618
Marketing Category NameANDA
Application NumberANDA040182
ManufacturerAPOTHECA, INC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength167; 2.5
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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