Package 65162-680-90
Brand: promethazine hydrochloride and dextromethorphan hydrobromide
Generic: promethazine hydrochloride and dextromethorphan hydrobromidePackage 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
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"}