oxybutynin

Product NDC
50090-5352
11-digit product format
500905352
Labeler code
50090
Product ID
50090-5352_890289a8-7be5-4750-b2a3-8b20c11650f3
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
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5352-0oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5352OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210615_4ef97dd9-77a1-49a3-896b-ea810efbbd53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN4ef97dd9-77a1-49a3-896b-ea810efbbd533
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD4ef97dd9-77a1-49a3-896b-ea810efbbd533
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY4ef97dd9-77a1-49a3-896b-ea810efbbd533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5352-05009053520090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5352-0) 2020-11-110000-00-00NoNoCurrent