Package 65162-039-03
Brand: guaifenesin and dextromethorphan hbr
Generic: guaifenesin and dextromethorphan hbrPackage Facts
Identity
Package NDC
65162-039-03
Digits Only
6516203903
Product NDC
65162-039
Description
1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing
Marketing Status
Brand
guaifenesin and dextromethorphan hbr
Generic
guaifenesin and dextromethorphan hbr
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "bdfe8cad-61bb-48eb-a5c4-ec21abde055a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0365162039030"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["cfdbcdb0-531a-4d95-ac5d-64d6d034b252"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-039-03", "marketing_start_date": "20181101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-039-06", "marketing_start_date": "20181101"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "65162-039-17", "marketing_start_date": "20181101"}], "brand_name": "Guaifenesin and Dextromethorphan HBr", "product_id": "65162-039_bdfe8cad-61bb-48eb-a5c4-ec21abde055a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "65162-039", "generic_name": "Guaifenesin and Dextromethorphan HBr", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan HBr", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA209692", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}