"65162-700-77" National Drug Code (NDC)

Dextromethorphan Polistirex Extended-release 1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE
(Amneal Pharmaceuticals LLC)

NDC Code65162-700-77
Package Description1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE
Product NDC65162-700
Product Type NameHUMAN OTC DRUG
Proprietary NameDextromethorphan Polistirex Extended-release
Non-Proprietary NameDextromethorphan Polistirex
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20170801
Marketing Category NameANDA
Application NumberANDA203133
ManufacturerAmneal Pharmaceuticals LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Strength30
Strength Unitmg/5mL
Pharmacy ClassesSigma-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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