Package 0574-1104-16

Brand: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Generic: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
NDC Package

Package Facts

Identity

Package NDC 0574-1104-16
Digits Only 0574110416
Product NDC 0574-1104
Description

473 mL in 1 BOTTLE, PLASTIC (0574-1104-16)

Marketing

Marketing Status
Marketed Since 2015-02-06
Brand brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Generic brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "aa6625e1-c78d-417a-bdf3-fc09a5b26966", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["06db369d-09fe-4ca2-b98c-705356b7c403"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0574-1104-04)", "package_ndc": "0574-1104-04", "marketing_start_date": "20150206"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0574-1104-16)", "package_ndc": "0574-1104-16", "marketing_start_date": "20150206"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "0574-1104_aa6625e1-c78d-417a-bdf3-fc09a5b26966", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "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": "0574-1104", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA205292", "marketing_category": "ANDA", "marketing_start_date": "20150206", "listing_expiration_date": "20261231"}