Package 65162-680-90

Brand: promethazine hydrochloride and dextromethorphan hydrobromide

Generic: promethazine hydrochloride and dextromethorphan hydrobromide
NDC Package

Package Facts

Identity

Package NDC 65162-680-90
Digits Only 6516268090
Product NDC 65162-680
Description

473 mL in 1 BOTTLE (65162-680-90)

Marketing

Marketing Status
Marketed Since 2011-03-04
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": "5897cff8-507a-42b0-bcf2-4712589704df", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["6081c216-0bed-40f0-8732-f999647003d5"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (65162-680-86)", "package_ndc": "65162-680-86", "marketing_start_date": "20110304"}, {"sample": false, "description": "473 mL in 1 BOTTLE (65162-680-90)", "package_ndc": "65162-680-90", "marketing_start_date": "20110304"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "65162-680_5897cff8-507a-42b0-bcf2-4712589704df", "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": "65162-680", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "ANDA090575", "marketing_category": "ANDA", "marketing_start_date": "20110304", "listing_expiration_date": "20261231"}