Package 50090-7658-0

Brand: promethazine hydrochloride and dextromethorphan hydrobromide

Generic: promethazine hydrochloride and dextromethorphan hydrobromide
NDC Package

Package Facts

Identity

Package NDC 50090-7658-0
Digits Only 5009076580
Product NDC 50090-7658
Description

473 mL in 1 BOTTLE, PLASTIC (50090-7658-0)

Marketing

Marketing Status
Marketed Since 2025-09-22
Brand promethazine hydrochloride and dextromethorphan hydrobromide
Generic promethazine hydrochloride and dextromethorphan hydrobromide
Sample Package No

Linked Drug Pages (0)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "7027c091-e34f-4697-a72c-6bf5e14b28dc", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["87f9e9fb-5433-478b-9f23-e16883a9d2a9"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (50090-7658-0)", "package_ndc": "50090-7658-0", "marketing_start_date": "20250922"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (50090-7658-1)", "package_ndc": "50090-7658-1", "marketing_start_date": "20250922"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "50090-7658_7027c091-e34f-4697-a72c-6bf5e14b28dc", "dosage_form": "SYRUP", "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": "50090-7658", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "A-S Medication Solutions", "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": "ANDA088864", "marketing_category": "ANDA", "marketing_start_date": "20250407", "listing_expiration_date": "20261231"}