NDC 52544-084

GELNIQUE

Oxybutynin Chloride

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

• Product ID: 52544-084_186f4c4a-e6c6-4263-bc32-b984512c974d
• NDC: 52544-084
• Product Type: Human Prescription Drug
• Proprietary Name: GELNIQUE
• Generic Name: Oxybutynin Chloride
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2009-05-15
• Marketing End Date: 2019-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA022204
• Labeler Name: Actavis Pharma, 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

Packaging

NDC 52544-084-30

30 PACKET in 1 CARTON (52544-084-30) > 1 g in 1 PACKET

• Marketing Start Date: 2009-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52544-084-30 [52544008430]

GELNIQUE GEL

• Marketing Category: NDA
• Application Number: NDA022204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-05-15
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
OXYBUTYNIN CHLORIDE	100 mg/g

OpenFDA Data

• SPL SET ID: acf0324b-2fac-4403-bac8-131b3e1cf5cd
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • L9F3D9RENQ
• RxNorm Concept Unique ID - RxCUI:
  • 864820
  • 864818

Pharmacological Class

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

Medicade Reported Pricing

52544084828 OGESTREL TABLET

Pricing Unit: EA | Drug Type:

52544084728 LOW-OGESTREL-28 TABLET

Pricing Unit: EA | Drug Type:

52544008430 GELNIQUE 10% GEL SACHETS

Pricing Unit: GM | Drug Type:

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