Package 62559-758-16

{"route": ["ORAL"], "spl_id": "d9ff674c-ec90-4e98-9d7e-cfab92649343", "openfda": {"upc": ["0362559758048"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["a52e210f-b99d-493e-b679-ec565c6ff72d"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (62559-758-04)", "package_ndc": "62559-758-04", "marketing_start_date": "20240905"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62559-758-16)", "package_ndc": "62559-758-16", "marketing_start_date": "20240905"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "62559-758_d9ff674c-ec90-4e98-9d7e-cfab92649343", "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": "62559-758", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "ANI Pharmaceuticals, 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"}