Package 57631-013-10

Brand: guaifenesin and dextromethorphan hydrobromide

Generic: guaifenesin and dextromethorphan hydrobromide
NDC Package

Package Facts

Identity

Package NDC 57631-013-10
Digits Only 5763101310
Product NDC 57631-013
Description

26500 TABLET in 1 BOX (57631-013-10)

Marketing

Marketing Status
Marketed Since 2021-01-13
Brand guaifenesin and dextromethorphan hydrobromide
Generic guaifenesin and dextromethorphan hydrobromide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "402896d4-831f-c53d-e063-6294a90a21b3", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147685"], "spl_set_id": ["40288ecf-043d-eb9e-e063-6394a90ac0a7"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["InvaTech Pharma Solutions LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "26500 TABLET in 1 BOX (57631-013-10)", "package_ndc": "57631-013-10", "marketing_start_date": "20210113"}], "brand_name": "Guaifenesin and Dextromethorphan Hydrobromide", "product_id": "57631-013_402896d4-831f-c53d-e063-6294a90a21b3", "dosage_form": "TABLET", "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": "57631-013", "generic_name": "Guaifenesin and Dextromethorphan Hydrobromide", "labeler_name": "InvaTech Pharma Solutions LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210113", "listing_expiration_date": "20261231"}