Package 0121-0933-16

Brand: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

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

Package Facts

Identity

Package NDC 0121-0933-16
Digits Only 0121093316
Product NDC 0121-0933
Description

473 mL in 1 BOTTLE (0121-0933-16)

Marketing

Marketing Status
Marketed Since 2022-03-03
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": "44a05fe1-89fe-4252-b0b8-1ce678a4c6a7", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["01ea6357-24dc-4056-9fd2-9e643650b91f"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0121-0933-04)", "package_ndc": "0121-0933-04", "marketing_start_date": "20220303"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0933-16)", "package_ndc": "0121-0933-16", "marketing_start_date": "20220303"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "0121-0933_44a05fe1-89fe-4252-b0b8-1ce678a4c6a7", "dosage_form": "SOLUTION", "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": "0121-0933", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "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": "ANDA202940", "marketing_category": "ANDA", "marketing_start_date": "20220303", "listing_expiration_date": "20261231"}