"59368-257-01" National Drug Code (NDC)

Signature Care Cough Relief 1 BOTTLE in 1 CARTON (59368-257-01) / 89 mL in 1 BOTTLE
(Praxis, LLC)

NDC Code59368-257-01
Package Description1 BOTTLE in 1 CARTON (59368-257-01) / 89 mL in 1 BOTTLE
Product NDC59368-257
Product Type NameHUMAN OTC DRUG
Proprietary NameSignature Care Cough Relief
Non-Proprietary NameDextromethorphan Polistirex
Dosage FormSUSPENSION, EXTENDED RELEASE
UsageORAL
Start Marketing Date20210708
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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