NDC 0023-5861

GELNIQUE

Oxybutynin Chloride

GELNIQUE is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Oxybutynin Chloride.

• Product ID: 0023-5861_74ccc9f4-e4c5-472a-9087-39389aefda50
• NDC: 0023-5861
• Product Type: Human Prescription Drug
• Proprietary Name: GELNIQUE
• Generic Name: Oxybutynin Chloride
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2017-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA022204
• Labeler Name: Allergan, Inc.
• Substance Name: OXYBUTYNIN CHLORIDE
• Active Ingredient Strength: 100 mg/g
• Pharm Classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0023-5861-11

30 PACKET in 1 CARTON (0023-5861-11) > 1 g in 1 PACKET

• Marketing Start Date: 2017-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-5861-11 [00023586111]

GELNIQUE GEL

• Marketing Category: NDA
• Application Number: NDA022204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-04-01

Drug Details

Active Ingredients

Ingredient	Strength
OXYBUTYNIN CHLORIDE	100 mg/g

OpenFDA Data

• SPL SET ID: 57616d79-9e68-4ec7-a25f-ebee07576351
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • L9F3D9RENQ
• RxNorm Concept Unique ID - RxCUI:
  • 864820
  • 864818

Pharmacological Class

• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]

NDC Crossover Matching brand name "GELNIQUE" or generic name "Oxybutynin Chloride"

NDC	Brand Name	Generic Name
0023-5812	GELNIQUE	oxybutynin chloride
0023-5861	GELNIQUE	oxybutynin chloride
52544-084	GELNIQUE	GELNIQUE
0093-5206	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
0093-5207	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
0093-5208	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
0121-0671	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
0179-0187	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE
0378-6605	Oxybutynin Chloride	oxybutynin chloride
0378-6610	Oxybutynin Chloride	oxybutynin chloride
0378-6615	Oxybutynin Chloride	oxybutynin chloride
0603-4975	Oxybutynin Chloride	oxybutynin chloride
0615-3512	Oxybutynin Chloride	Oxybutynin Chloride
0615-7519	Oxybutynin Chloride	oxybutynin chloride
0615-7520	Oxybutynin Chloride	oxybutynin chloride
0615-7521	oxybutynin chloride	oxybutynin chloride
0615-8428	Oxybutynin Chloride	oxybutynin chloride
0832-0038	Oxybutynin Chloride	Oxybutynin Chloride
0904-2821	Oxybutynin Chloride	Oxybutynin Chloride
0904-6570	Oxybutynin Chloride	Oxybutynin Chloride
0904-7027	Oxybutynin Chloride	Oxybutynin Chloride
10135-609	Oxybutynin Chloride	Oxybutynin Chloride
10135-610	Oxybutynin Chloride	Oxybutynin Chloride
10135-611	Oxybutynin Chloride	Oxybutynin Chloride
10135-640	Oxybutynin Chloride	Oxybutynin Chloride