Package 50090-7658-0
Brand: promethazine hydrochloride and dextromethorphan hydrobromide
Generic: promethazine hydrochloride and dextromethorphan hydrobromidePackage 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
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"}