"53002-4260-1" National Drug Code (NDC)

Promethazine Dm 118 mL in 1 BOTTLE (53002-4260-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-4260-1
Package Description118 mL in 1 BOTTLE (53002-4260-1)
Product NDC53002-4260
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Dm
Non-Proprietary NameDextromethorphan Hydrobromide And Promethazine Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20060214
Marketing Category NameANDA
Application NumberANDA040649
ManufacturerRPK 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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