"68788-8100-1" National Drug Code (NDC)

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution 118 mL in 1 BOTTLE (68788-8100-1)
(Preferred Pharmaceuticals Inc.)

NDC Code68788-8100-1
Package Description118 mL in 1 BOTTLE (68788-8100-1)
Product NDC68788-8100
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution
Non-Proprietary NamePromethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20211008
Marketing Category NameANDA
Application NumberANDA040649
ManufacturerPreferred 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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