Package 71205-654-04
Brand: promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solutionPackage 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
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"}