Oxybutynin Chloride

Product NDC
50090-4728
11-digit product format
500904728
Labeler code
50090
Product ID
50090-4728_c3337d7f-6feb-4cd1-b8f4-7320f6770010
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204010
Marketing category
ANDA
Marketing start
2015-11-02
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
50090-4728-0Oxybutynin Chloride90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4728OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210615_cdcfce4c-d2a1-43b3-8bf5-0ac102d857ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNcdcfce4c-d2a1-43b3-8bf5-0ac102d857ae5
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDcdcfce4c-d2a1-43b3-8bf5-0ac102d857ae5
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYcdcfce4c-d2a1-43b3-8bf5-0ac102d857ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4728-05009047280090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4728-0) 2019-11-180000-00-00NoNoCurrent