"0574-1105-16" National Drug Code (NDC)

Hydrocodone Bitartrate And Homatropine Methylbromide 473 mL in 1 BOTTLE (0574-1105-16)
(Paddock Laboratories, LLC)

NDC Code0574-1105-16
Package Description473 mL in 1 BOTTLE (0574-1105-16)
Product NDC0574-1105
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Homatropine Methylbromide
Non-Proprietary NameHydrocodone Bitartrate, Homatropine Methylbromide
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20170616
End Marketing Date20190531
Marketing Category NameANDA
Application NumberANDA205731
ManufacturerPaddock Laboratories, LLC
Substance NameHYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Strength5; 1.5
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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