"62559-758-16" National Drug Code (NDC)

Promethazine Hydrochloride And Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE (62559-758-16)
(ANI Pharmaceuticals, Inc.)

NDC Code62559-758-16
Package Description473 mL in 1 BOTTLE (62559-758-16)
Product NDC62559-758
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride And Dextromethorphan Hydrobromide
Non-Proprietary NamePromethazine Hydrochloride And Dextromethorphan Hydrobromide
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20240905
Marketing Category NameNDA AUTHORIZED GENERIC
Application NumberNDA011265
ManufacturerANI Pharmaceuticals, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Strength15; 6.25
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesPhenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]

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