Package 68071-3551-4

Brand: promethazine hydrochloride and dextromethorphan hydrobromide oral solution

Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solution
NDC Package

Package 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
Marketed Since 2023-12-01
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"}