FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
43353-367
11-digit product format
433530367
Labeler code
43353
Product ID
43353-367_f1a9c987-5f09-45f3-8c21-8a8cbc34cf88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075079
Marketing category
ANDA
Marketing start
1997-10-31
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
43353-367-302023-01-30C16284748780-1f386c64a-103b-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP
43353-367-602023-01-30C16284748780-1f386c64a-103b-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP
43353-367-802023-01-30C16284748780-1f386c64a-103b-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP
43353-367-922023-01-30C16284748780-1f386c64a-103b-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-367-30Oxybutynin Chloride30 in 1 BOTTLE, PLASTICTABLET302
43353-367-60Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET902
43353-367-80Oxybutynin Chloride180 in 1 BOTTLE, PLASTICTABLET1802
43353-367-92Oxybutynin Chloride270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-367OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20191221_fad7574c-07fc-4311-90ea-5ccc7244e782.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNfad7574c-07fc-4311-90ea-5ccc7244e7822
863664oxybutynin chloride 5 MG Oral TabletSCDfad7574c-07fc-4311-90ea-5ccc7244e7822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-367-304335303673030 TABLET in 1 BOTTLE, PLASTIC (43353-367-30) 30 tablet2008-10-100000-00-00NoNoCurrent
43353-367-604335303676090 TABLET in 1 BOTTLE, PLASTIC (43353-367-60) 90 tablet2011-01-160000-00-00NoNoCurrent
43353-367-8043353036780180 TABLET in 1 BOTTLE, PLASTIC (43353-367-80) 180 tablet2011-01-200000-00-00NoNoCurrent
43353-367-9243353036792270 TABLET in 1 BOTTLE, PLASTIC (43353-367-92) 270 tablet2011-08-310000-00-00NoNoCurrent