"66576-335-01" National Drug Code (NDC)

NDC Code	66576-335-01
Package Description	100 TABLET in 1 BOTTLE (66576-335-01)
Product NDC	66576-335
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Giltuss Tr
Non-Proprietary Name	Guaifenesin,dextromethorphan Hbr,phenylephrine Hcl
Dosage Form	TABLET
Usage	ORAL
Start Marketing Date	20220107
Marketing Category Name	OTC MONOGRAPH FINAL
Application Number	part341
Manufacturer	Syntho Pharmaceuticals, Inc.
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Strength	29; 390; 10
Strength Unit	mg/1; mg/1; mg/1
Pharmacy Classes	Adrenergic alpha1-Agonists [MoA], Decreased 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], alpha-1 Adrenergic Agonist [EPC]