"52083-653-16" National Drug Code (NDC)

NDC Code	52083-653-16
Package Description	480 mL in 1 BOTTLE (52083-653-16)
Product NDC	52083-653
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Presgen Pediatric
Non-Proprietary Name	Guaifenesin, Phenylephrine Hcl,dextromethorphan Hydrobromide
Dosage Form	SYRUP
Usage	ORAL
Start Marketing Date	20110324
Marketing Category Name	OTC MONOGRAPH FINAL
Application Number	part341
Manufacturer	KRAMER NOVIS
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Strength	5; 75; 2.5
Strength Unit	mg/5mL; mg/5mL; mg/5mL
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]