"59368-249-01" National Drug Code (NDC)

Leader Childrens Cough Dm 1 BOTTLE in 1 CARTON (59368-249-01) / 89 mL in 1 BOTTLE
(Praxis, LLC)

NDC Code59368-249-01
Package Description1 BOTTLE in 1 CARTON (59368-249-01) / 89 mL in 1 BOTTLE
Product NDC59368-249
Product Type NameHUMAN OTC DRUG
Proprietary NameLeader Childrens Cough Dm
Non-Proprietary NameDextromethorphan Polistirex
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20161115
Marketing Category NameANDA
Application NumberANDA091135
ManufacturerPraxis, 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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