brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphanhydrobromide

Generic: brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphanhydrobromide
Generic Name brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
Labeler proficient rx lp
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-400
Product ID 63187-400_7f00edf4-7b75-4ba8-9685-5f7c6326d0ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088811
Listing Expiration 2026-12-31
Marketing Start 2010-06-15

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 63187400
Hyphenated Format 63187-400

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 dextromethorphanhydrobromide (source: ndc)
Generic Name brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide (source: ndc)
Application Number ANDA088811 (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 (63187-400-04)
source: ndc

Packages (1)

63187-400-04 118 mL in 1 BOTTLE, PLASTIC (63187-400-04)

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 DextromethorphanHydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f00edf4-7b75-4ba8-9685-5f7c6326d0ac", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["871632bb-0525-4e3b-a3ab-a50393bc9634"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (63187-400-04)", "package_ndc": "63187-400-04", "marketing_start_date": "20190101"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide", "product_id": "63187-400_7f00edf4-7b75-4ba8-9685-5f7c6326d0ac", "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": "63187-400", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide", "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": "ANDA088811", "marketing_category": "ANDA", "marketing_start_date": "20100615", "listing_expiration_date": "20261231"}