"45802-433-21" National Drug Code (NDC)

Dextromethorphan Polistirex Extended Release 1 BOTTLE in 1 CARTON (45802-433-21) > 89 mL in 1 BOTTLE
(Padagis Israel Pharmaceuticals Ltd)

NDC Code45802-433-21
Package Description1 BOTTLE in 1 CARTON (45802-433-21) > 89 mL in 1 BOTTLE
Product NDC45802-433
Product Type NameHUMAN OTC DRUG
Proprietary NameDextromethorphan Polistirex Extended Release
Non-Proprietary NameDextromethorphan Polistirex
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20120910
Marketing Category NameANDA
Application NumberANDA091135
ManufacturerPadagis Israel Pharmaceuticals Ltd
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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