Oxybutynin Chloride

Product NDC
53808-1122
11-digit product format
538081122
Labeler code
53808
Product ID
53808-1122_71b66fc9-7e62-40a5-ada5-8fc45165bfac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA209335
Marketing category
ANDA
Marketing start
2018-07-10
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
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1122-12024-01-30C16284748780-11030e365-0457-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1122-1Oxybutynin Chloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1122OXYBUTYNIN CHLORIDE TABLET [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190123_8189da24-31df-428f-bae5-b249779a9057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN8189da24-31df-428f-bae5-b249779a90571
863664oxybutynin chloride 5 MG Oral TabletSCD8189da24-31df-428f-bae5-b249779a90571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53808-1122-15380811220130 TABLET in 1 BLISTER PACK (53808-1122-1) 30 tablet2018-07-100000-00-00NoNoCurrent