Package 0116-4024-16

Brand: promethazine hydrochloride and dextromethorphan hydrobromide

Generic: promethazine hydrochloride and dextromethorphan hydrobromide
NDC Package

Package Facts

Identity

Package NDC 0116-4024-16
Digits Only 0116402416
Product NDC 0116-4024
Description

473 mL in 1 BOTTLE, PLASTIC (0116-4024-16)

Marketing

Marketing Status
Marketed Since 2025-04-07
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": "30c9dc19-5091-17dd-e063-6394a90a51f9", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["30c9d769-bc74-04d2-e063-6294a90a665a"], "manufacturer_name": ["Xttrium Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0116-4024-16)", "package_ndc": "0116-4024-16", "marketing_start_date": "20250407"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "0116-4024_30c9dc19-5091-17dd-e063-6394a90a51f9", "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": "0116-4024", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Xttrium Laboratories, 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": "ANDA088864", "marketing_category": "ANDA", "marketing_start_date": "20250407", "listing_expiration_date": "20261231"}