Package 71205-654-04

Brand: promethazine hydrochloride and dextromethorphan hydrobromide oral solution

Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solution
NDC Package

Package Facts

Identity

Package NDC 71205-654-04
Digits Only 7120565404
Product NDC 71205-654
Description

118 mL in 1 BOTTLE (71205-654-04)

Marketing

Marketing Status
Marketed Since 2022-04-26
Brand promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Generic promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "68a4c521-6db0-4e94-9906-96e96e251301", "openfda": {"upc": ["0371205654047"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["68a4c521-6db0-4e94-9906-96e96e251301"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (71205-654-04)", "package_ndc": "71205-654-04", "marketing_start_date": "20220426"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "product_id": "71205-654_68a4c521-6db0-4e94-9906-96e96e251301", "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": "71205-654", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040649", "marketing_category": "ANDA", "marketing_start_date": "20201005", "listing_expiration_date": "20261231"}