brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Generic: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Generic Name brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Labeler remedyrepack inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

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

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4526
Product ID 70518-4526_4844c0ef-a0c8-f296-e063-6394a90a8c73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205292
Listing Expiration 2027-12-31
Marketing Start 2025-12-01

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 705184526
Hyphenated Format 70518-4526

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
  • 3 CUP in 1 BOX (70518-4526-0) / 20 mL in 1 CUP (70518-4526-1)
  • 6 CUP in 1 BOX (70518-4526-2) / 10 mL in 1 CUP (70518-4526-3)
  • 12 CUP in 1 BOX (70518-4526-4) / 5 mL in 1 CUP (70518-4526-5)
source: ndc

Packages (3)

70518-4526-0 3 CUP in 1 BOX (70518-4526-0) / 20 mL in 1 CUP (70518-4526-1) 70518-4526-2 6 CUP in 1 BOX (70518-4526-2) / 10 mL in 1 CUP (70518-4526-3) 70518-4526-4 12 CUP in 1 BOX (70518-4526-4) / 5 mL in 1 CUP (70518-4526-5)

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": "4844c0ef-a0c8-f296-e063-6394a90a8c73", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["35236e4a-6e98-4c4d-85bf-7551fd08d700"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "3 CUP in 1 BOX (70518-4526-0)  / 20 mL in 1 CUP (70518-4526-1)", "package_ndc": "70518-4526-0", "marketing_start_date": "20251201"}, {"sample": false, "description": "6 CUP in 1 BOX (70518-4526-2)  / 10 mL in 1 CUP (70518-4526-3)", "package_ndc": "70518-4526-2", "marketing_start_date": "20251210"}, {"sample": false, "description": "12 CUP in 1 BOX (70518-4526-4)  / 5 mL in 1 CUP (70518-4526-5)", "package_ndc": "70518-4526-4", "marketing_start_date": "20260112"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "70518-4526_4844c0ef-a0c8-f296-e063-6394a90a8c73", "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": "70518-4526", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "REMEDYREPACK INC.", "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": "20251201", "listing_expiration_date": "20271231"}