brompheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide

Generic: brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide

Labeler: acella pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brompheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide
Generic Name brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
Labeler acella pharmaceuticals, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

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

Manufacturer
Acella Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42192-607
Product ID 42192-607_40203da6-7693-e5f5-e063-6394a90ab7b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203375
Listing Expiration 2026-12-31
Marketing Start 2016-09-21

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 42192607
Hyphenated Format 42192-607

Supplemental Identifiers

RxCUI
1357010
UPC
0342192607057 0342192607040 0342192607163
UNII
IXA7C9ZN03 9D2RTI9KYH 6V9V2RYJ8N

Packaging Origin

Original Packager
true

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, dextromethorphan hydrobromide (source: ndc)
Generic Name brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide (source: ndc)
Application Number ANDA203375 (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 (42192-607-04)
  • 473 mL in 1 BOTTLE, PLASTIC (42192-607-16)
  • 40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)
source: ndc

Packages (3)

42192-607-04 118 mL in 1 BOTTLE, PLASTIC (42192-607-04) 42192-607-16 473 mL in 1 BOTTLE, PLASTIC (42192-607-16) 42192-607-40 40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)

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, Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40203da6-7693-e5f5-e063-6394a90ab7b3", "openfda": {"upc": ["0342192607057", "0342192607040", "0342192607163"], "unii": ["IXA7C9ZN03", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1357010"], "spl_set_id": ["1045e307-f60d-482d-8e06-40e72b84c651"], "manufacturer_name": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (42192-607-04)", "package_ndc": "42192-607-04", "marketing_start_date": "20160921"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (42192-607-16)", "package_ndc": "42192-607-16", "marketing_start_date": "20160921"}, {"sample": false, "description": "40 CUP, UNIT-DOSE in 1 CASE (42192-607-40)  / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)", "package_ndc": "42192-607-40", "marketing_start_date": "20160921"}], "brand_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide", "product_id": "42192-607_40203da6-7693-e5f5-e063-6394a90ab7b3", "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": "42192-607", "generic_name": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, 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": "ANDA203375", "marketing_category": "ANDA", "marketing_start_date": "20160921", "listing_expiration_date": "20261231"}