Package 50991-535-01
Brand: duraflu
Generic: acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hclPackage Facts
Identity
Package NDC
50991-535-01
Digits Only
5099153501
Product NDC
50991-535
Description
100 TABLET in 1 BOTTLE (50991-535-01)
Marketing
Marketing Status
Brand
duraflu
Generic
acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2683803e-5e2f-b2bc-e063-6394a90a4feb", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1673869"], "spl_set_id": ["55fffc1d-8449-4c28-a391-c6f60dd85622"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50991-535-01)", "package_ndc": "50991-535-01", "marketing_start_date": "20151001"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (50991-535-02) / 2 TABLET in 1 BLISTER PACK", "package_ndc": "50991-535-02", "marketing_start_date": "20151001"}], "brand_name": "Duraflu", "product_id": "50991-535_2683803e-5e2f-b2bc-e063-6394a90a4feb", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-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-Adrenergic Agonist [EPC]"], "product_ndc": "50991-535", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Duraflu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20151001", "listing_expiration_date": "20261231"}