Package 65162-039-03

Brand: guaifenesin and dextromethorphan hbr

Generic: guaifenesin and dextromethorphan hbr
NDC Package

Package 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
Marketed Since 2018-11-01
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"}