Package 0121-1070-04

{"route": ["ORAL"], "spl_id": "acf1463f-bbbe-42e9-9b06-a306e95a4325", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["1d47280d-28c9-4701-8c5f-a6e6b524083b"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0121-1070-04)", "package_ndc": "0121-1070-04", "marketing_start_date": "20250604"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-1070-16)", "package_ndc": "0121-1070-16", "marketing_start_date": "20250604"}], "brand_name": "Promethazine DM", "product_id": "0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325", "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": "0121-1070", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040649", "marketing_category": "ANDA", "marketing_start_date": "20250604", "listing_expiration_date": "20261231"}