GELNIQUE

Product NDC
52544-084
11-digit product format
525440084
Labeler code
52544
Product ID
52544-084_186f4c4a-e6c6-4263-bc32-b984512c974d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Actavis Pharma, Inc.
Application
NDA022204
Marketing category
NDA
Marketing start
2009-05-15
Marketing end
2019-06-30
Substance
OXYBUTYNIN CHLORIDE
Active strength
100 mg/g
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-084-30GM - Gram52544-0845a4af330-c695-41f9-a035-a083f581183612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQGELNIQUE (OXYBUTYNIN CHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092GELNIQUE (OXYBUTYNIN CHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]1