brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide (50090-5625)

Drug Facts

Product Profile

Brand Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Generic Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Labeler a-s medication solutions

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

brompheniramine maleate 2 mg/5mL, dextromethorphan hydrobromide 10 mg/5mL, pseudoephedrine hydrochloride 30 mg/5mL

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5625

Product ID 50090-5625_22aab262-5705-4bdf-b195-78a8cb601669

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205292

Listing Expiration 2026-12-31

Marketing Start 2015-02-06

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905625

Hyphenated Format 50090-5625

Supplemental Identifiers

RxCUI

1357010

UNII

IXA7C9ZN03 9D2RTI9KYH 6V9V2RYJ8N

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide (source: ndc)

Generic Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide (source: ndc)

Application Number ANDA205292 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2 mg/5mL
10 mg/5mL
30 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE, PLASTIC (50090-5625-0)

source: ndc

Packages (1)

50090-5625-0 118 mL in 1 BOTTLE, PLASTIC (50090-5625-0)

Ingredients (3)

brompheniramine maleate (2 mg/5mL) dextromethorphan hydrobromide (10 mg/5mL) pseudoephedrine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "22aab262-5705-4bdf-b195-78a8cb601669", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["440d0554-995c-47df-b9f6-f3e3ce2e35e0"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (50090-5625-0)", "package_ndc": "50090-5625-0", "marketing_start_date": "20210831"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "50090-5625_22aab262-5705-4bdf-b195-78a8cb601669", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50090-5625", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA205292", "marketing_category": "ANDA", "marketing_start_date": "20150206", "listing_expiration_date": "20261231"}