"0904-6758-16" National Drug Code (NDC)

Robafen 473 mL in 1 BOTTLE (0904-6758-16)
(Major Pharmaceuticals)

NDC Code0904-6758-16
Package Description473 mL in 1 BOTTLE (0904-6758-16)
Product NDC0904-6758
Product Type NameHUMAN OTC DRUG
Proprietary NameRobafen
Non-Proprietary NameDextromethorphan Hbr, Guaifenesin
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20180813
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart341
ManufacturerMajor Pharmaceuticals
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Strength20; 200
Strength Unitmg/10mL; mg/10mL
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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