qbrexza

Generic: glycopyrronium

Labeler: journey medical corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name qbrexza
Generic Name glycopyrronium
Labeler journey medical corporation
Dosage Form CLOTH
Routes
TOPICAL
Active Ingredients

glycopyrronium tosylate 2.4 g/100g

Manufacturer
Journey Medical Corporation

Identifiers & Regulatory

Product NDC 69489-411
Product ID 69489-411_78796126-f6ed-42e3-b40d-ea5723b89516
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210361
Listing Expiration 2026-12-31
Marketing Start 2018-06-28

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69489411
Hyphenated Format 69489-411

Supplemental Identifiers

RxCUI
2054118 2054120
UNII
1PVF6JLU7B

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 qbrexza (source: ndc)
Generic Name glycopyrronium (source: ndc)
Application Number NDA210361 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.4 g/100g
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51)
  • 30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01)
source: ndc

Packages (2)

69489-411-05 5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51) 69489-411-30 30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01)

Ingredients (1)

glycopyrronium tosylate (2.4 g/100g)

Linked Drug Pages (1)

Qbrexza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "78796126-f6ed-42e3-b40d-ea5723b89516", "openfda": {"unii": ["1PVF6JLU7B"], "rxcui": ["2054118", "2054120"], "spl_set_id": ["5b372650-e56e-47a5-93e2-c0c292017059"], "manufacturer_name": ["Journey Medical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "5 POUCH in 1 CARTON (69489-411-05)  / 2.8 g in 1 POUCH (69489-411-51)", "package_ndc": "69489-411-05", "marketing_start_date": "20211203"}, {"sample": false, "description": "30 POUCH in 1 CARTON (69489-411-30)  / 2.8 g in 1 POUCH (69489-411-01)", "package_ndc": "69489-411-30", "marketing_start_date": "20211203"}], "brand_name": "Qbrexza", "product_id": "69489-411_78796126-f6ed-42e3-b40d-ea5723b89516", "dosage_form": "CLOTH", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "69489-411", "generic_name": "glycopyrronium", "labeler_name": "Journey Medical Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Qbrexza", "active_ingredients": [{"name": "GLYCOPYRRONIUM TOSYLATE", "strength": "2.4 g/100g"}], "application_number": "NDA210361", "marketing_category": "NDA", "marketing_start_date": "20180628", "listing_expiration_date": "20261231"}