"0054-0843-63" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 473 mL in 1 BOTTLE (0054-0843-63)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0843-63
Package Description473 mL in 1 BOTTLE (0054-0843-63)
Product NDC0054-0843
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormLIQUID
UsageORAL
Start Marketing Date20250602
Marketing Category NameANDA
Application NumberANDA040881
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength300; 10
Strength Unitmg/15mL; mg/15mL
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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