Package 0713-0780-75
Brand: promethazine hydrochloride and dextromethorphan hydrobromide
Generic: promethazine hydrochloride and dextromethorphan hydrobromidePackage Facts
Identity
Package NDC
0713-0780-75
Digits Only
0713078075
Product NDC
0713-0780
Description
473 mL in 1 BOTTLE, PLASTIC (0713-0780-75)
Marketing
Marketing Status
Brand
promethazine hydrochloride and dextromethorphan hydrobromide
Generic
promethazine 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": "3f7c7c58-c76e-b49c-e063-6294a90ace09", "openfda": {"upc": ["0307130780759"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["e7b336d9-b1df-4a08-9b67-754346d365f4"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0713-0780-75)", "package_ndc": "0713-0780-75", "marketing_start_date": "20250919"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "0713-0780_3f7c7c58-c76e-b49c-e063-6294a90ace09", "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": "0713-0780", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Cosette 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": "ANDA091687", "marketing_category": "ANDA", "marketing_start_date": "20250919", "listing_expiration_date": "20261231"}