FDA.reportPublic FDA data

Oxytrol for Women

Product NDC
0023-9637
11-digit product format
000239637
Labeler code
0023
Product ID
0023-9637_cc404430-2345-4294-8efc-e1e996cc17b2
Type
HUMAN OTC DRUG
Nonproprietary name
Oxybutynin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Allergan, Inc.
Application
NDA202211
Marketing category
NDA
Marketing start
2016-01-01
Substance
OXYBUTYNIN
Active strength
3.9 mg/d
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxytrol for Women
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN3.9 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK9P6MC7092
Rxcui403799, 404448

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-9637-04Oxytrol for Women4 d in 1 PATCHPATCH47
0023-9637-04Oxytrol for Women16 in 1 CARTONPATCH167
0023-9637-08Oxytrol for Women32 in 1 CARTONPATCH327
0023-9637-08Oxytrol for Women4 d in 1 PATCHPATCH47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9637-04EA - Each0023-963737642404-e98d-40ac-a2c1-985cd0ee49af12020-02-13
0023-9637-08EA - Each0023-9637d665755a-2d3f-4a15-8e3c-978fafad4c8412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9637OXYTROL FOR WOMEN (OXYBUTYNIN) PATCH [ALLERGAN, INC.]7Current NDC, Legacy NDC, 4 package rows20250109_8cdc5b4d-ff8d-4010-97d7-313422a0b868.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403799oxyBUTYnin 3.9 MG/Day Twice Weekly Transdermal SystemPSN8cdc5b4d-ff8d-4010-97d7-313422a0b8687
404448OXYTROL 3.9 MG/Day Twice Weekly Transdermal SystemPSN8cdc5b4d-ff8d-4010-97d7-313422a0b8687
40444884 HR oxybutynin 0.162 MG/HR Transdermal System [Oxytrol]SBD8cdc5b4d-ff8d-4010-97d7-313422a0b8687
40379984 HR oxybutynin 0.162 MG/HR Transdermal SystemSCD8cdc5b4d-ff8d-4010-97d7-313422a0b8687
40444884 HR Oxytrol 0.162 MG/HR Transdermal SystemSY8cdc5b4d-ff8d-4010-97d7-313422a0b8687
403799oxybutynin 0.162 MG/HR 84 HR Transdermal PatchSY8cdc5b4d-ff8d-4010-97d7-313422a0b8687
403799oxybutynin 3.9 MG/Day Twice Weekly Transdermal PatchSY8cdc5b4d-ff8d-4010-97d7-313422a0b8687
403799oxybutynin 3.9 MG/Day Twice Weekly Transdermal SystemSY8cdc5b4d-ff8d-4010-97d7-313422a0b8687
404448Oxytrol 3.9 MG/Day Twice Weekly Transdermal PatchSY8cdc5b4d-ff8d-4010-97d7-313422a0b8687
404448OXYTROL 3.9 MG/Day Twice Weekly Transdermal SystemSY8cdc5b4d-ff8d-4010-97d7-313422a0b8687

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-9637-040002396370416 PATCH in 1 CARTON (0023-9637-04) / 4 d in 1 PATCH16 patch2016-01-010000-00-00NoNoCurrent
0023-9637-080002396370832 PATCH in 1 CARTON (0023-9637-08) / 4 d in 1 PATCH32 patch2019-10-010000-00-00NoNoCurrent