Package 42192-630-04

{"route": ["ORAL"], "spl_id": "4138efd9-8584-c8db-e063-6294a90adcd7", "openfda": {"upc": ["0342192630048", "0342192630161"], "unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["0c403f27-0b9b-4da3-a66b-1040eff1b2bf"], "manufacturer_name": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (42192-630-04)", "package_ndc": "42192-630-04", "marketing_start_date": "20250201"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (42192-630-16)", "package_ndc": "42192-630-16", "marketing_start_date": "20250201"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide", "product_id": "42192-630_4138efd9-8584-c8db-e063-6294a90adcd7", "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": "42192-630", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, 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": "ANDA203375", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}