"65162-039-17" National Drug Code (NDC)

Guaifenesin And Dextromethorphan Hbr 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
(Amneal Pharmaceuticals LLC)

NDC Code65162-039-17
Package Description2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product NDC65162-039
Product Type NameHUMAN OTC DRUG
Proprietary NameGuaifenesin And Dextromethorphan Hbr
Non-Proprietary NameGuaifenesin And Dextromethorphan Hbr
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20181101
Marketing Category NameANDA
Application NumberANDA209692
ManufacturerAmneal Pharmaceuticals LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Strength60; 1200
Strength Unitmg/1; mg/1
Pharmacy ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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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