Package 0121-0933-04
Brand: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Generic: brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromidePackage Facts
Identity
Package NDC
0121-0933-04
Digits Only
0121093304
Product NDC
0121-0933
Description
118 mL in 1 BOTTLE (0121-0933-04)
Marketing
Marketing Status
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"}