Package 52083-653-16
Brand: presgen pediatric
Generic: guaifenesin, phenylephrine hcl,dextromethorphan hydrobromidePackage Facts
Identity
Package NDC
52083-653-16
Digits Only
5208365316
Product NDC
52083-653
Description
480 mL in 1 BOTTLE (52083-653-16)
Marketing
Marketing Status
Brand
presgen pediatric
Generic
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6fa9d05a-47dd-4ede-b77b-ada155683617", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1119541"], "spl_set_id": ["12fb91e5-6059-4b3a-a2de-762aa51a25b7"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KRAMER NOVIS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "480 mL in 1 BOTTLE (52083-653-16)", "package_ndc": "52083-653-16", "marketing_start_date": "20110324"}], "brand_name": "PRESGEN PEDIATRIC", "product_id": "52083-653_6fa9d05a-47dd-4ede-b77b-ada155683617", "dosage_form": "SYRUP", "pharm_class": ["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]"], "product_ndc": "52083-653", "generic_name": "GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE", "labeler_name": "KRAMER NOVIS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PRESGEN PEDIATRIC", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "75 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110324", "listing_expiration_date": "20261231"}