Package 76420-335-04

{"route": ["ORAL"], "spl_id": "348f2d59-90ce-1534-e063-6294a90a960a", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["702eb7c0-db4c-4729-b69e-99f64c63c7bd"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (76420-335-04)", "package_ndc": "76420-335-04", "marketing_start_date": "20250422"}, {"sample": false, "description": "473 mL in 1 BOTTLE (76420-335-16)", "package_ndc": "76420-335-16", "marketing_start_date": "20250422"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "76420-335_348f2d59-90ce-1534-e063-6294a90a960a", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "76420-335", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "NDA011265", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240905", "listing_expiration_date": "20261231"}