FDA.reportPublic FDA data

oxybutynin

Product NDC
50090-5353
11-digit product format
500905353
Labeler code
50090
Product ID
50090-5353_2d660e74-e22d-4493-9e7b-51c8031c3c69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202332
Marketing category
ANDA
Marketing start
2017-08-10
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 mg/1
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
oxybutynin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5353-02023-02-06C16284748780-1f386c649-c395-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS. OXYBUTYNIN CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1975
50090-5353-02023-01-30C16284748780-1f386c649-c395-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS. OXYBUTYNIN CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5353-0oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5353-0EA - Each50090-5353ab94ab49-2957-4c39-9aac-2dfe739baf7312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5353OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230208_1f95920c-5dc2-44e4-b61d-b2c5e05390ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN1f95920c-5dc2-44e4-b61d-b2c5e05390ba5
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD1f95920c-5dc2-44e4-b61d-b2c5e05390ba5
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY1f95920c-5dc2-44e4-b61d-b2c5e05390ba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5353-05009053530090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5353-0) 2020-11-110000-00-00NoNoCurrent