NDC 70428-011

Qbrexza

Glycopyrronium

Qbrexza is a Topical Cloth in the Human Prescription Drug category. It is labeled and distributed by Dermira, Inc.. The primary component is Glycopyrronium Tosylate.

• Product ID: 70428-011_bedc4fc0-e567-4763-bb73-e465531945a2
• NDC: 70428-011
• Product Type: Human Prescription Drug
• Proprietary Name: Qbrexza
• Generic Name: Glycopyrronium
• Dosage Form: Cloth
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-06-28
• Marketing Category: NDA / NDA
• Application Number: NDA210361
• Labeler Name: Dermira, Inc.
• Substance Name: GLYCOPYRRONIUM TOSYLATE
• Active Ingredient Strength: 2 g/100g
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70428-011-12

30 POUCH in 1 CARTON (70428-011-12) > 2.8 g in 1 POUCH (70428-011-11)

• Marketing Start Date: 2018-06-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70428-011-11 [70428001111]

Qbrexza CLOTH

• Marketing Category: NDA
• Application Number: NDA210361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-28

NDC 70428-011-12 [70428001112]

Qbrexza CLOTH

• Marketing Category: NDA
• Application Number: NDA210361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-28

Drug Details

Active Ingredients

Ingredient	Strength
GLYCOPYRRONIUM TOSYLATE	2.4 g/100g

OpenFDA Data

• SPL SET ID: 6b985380-1256-4fb3-b89a-6df2c6a6d12e
• Manufacturer:
  • Dermira, Inc.
• UNII:
  • 1PVF6JLU7B
• RxNorm Concept Unique ID - RxCUI:
  • 2054118
  • 2054120

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

Medicade Reported Pricing

70428001112 QBREXZA 2.4% CLOTH

Pricing Unit: EA | Drug Type:

70428001111 QBREXZA 2.4% CLOTH

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Qbrexza" or generic name "Glycopyrronium"

NDC	Brand Name	Generic Name
69489-411	Qbrexza	glycopyrronium
70428-011	Qbrexza	glycopyrronium