FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
69189-6605
11-digit product format
691896605
Labeler code
69189
Product ID
69189-6605_f0dac68c-e4c0-4857-bbff-83ff9ae73520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
ANDA076702
Marketing category
ANDA
Marketing start
2015-03-10
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
E
Listing certified through
2017-12-31
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
69189-6605-12020-01-31C16284748780-19d75b9d0-cdf9-f424-e053-dadaa90a57ceThese 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, USP for oral use Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-6605-1Oxybutynin Chloride1 in 1 DOSE PACKTABLET, FILM COATED, EXTENDED RE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-6605OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20160302_32a742f5-a683-46ba-90dd-5778b2c00308.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN32a742f5-a683-46ba-90dd-5778b2c003081
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD32a742f5-a683-46ba-90dd-5778b2c003081
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY32a742f5-a683-46ba-90dd-5778b2c003081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-6605-1691896605011 in 1 DOSE PACKHistorical