Package 68071-3551-4
Brand: promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solutionPackage Facts
Identity
Package NDC
68071-3551-4
Digits Only
6807135514
Product NDC
68071-3551
Description
118 mL in 1 BOTTLE (68071-3551-4)
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": "2d3fb2d4-6352-3f26-e063-6294a90a0163", "openfda": {"upc": ["0368071355147"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["0b7bfbab-decb-970c-e063-6394a90a50ef"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (68071-3551-4)", "package_ndc": "68071-3551-4", "marketing_start_date": "20231201"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "product_id": "68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163", "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": "68071-3551", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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"}