Oxybutynin Chloride

Product NDC
10135-640
11-digit product format
101350640
Labeler code
10135
Product ID
10135-640_76849892-9485-4e00-990b-81e7dcc2fca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA209823
Marketing category
ANDA
Marketing start
2018-04-01
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
10135-640-012021-01-29C16284748780-1ba0f9c33-3eac-a910-e053-dadaa90a0b85Oxybutynin Chloride Tablets
10135-640-052021-01-29C16284748780-1ba0f9c33-3eac-a910-e053-dadaa90a0b85Oxybutynin Chloride Tablets
10135-640-102021-01-29C16284748780-1ba0f9c33-3eac-a910-e053-dadaa90a0b85Oxybutynin Chloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-640-01Oxybutynin Chloride100 in 1 BOTTLETABLET1002
10135-640-05Oxybutynin Chloride500 in 1 BOTTLETABLET5002
10135-640-10Oxybutynin Chloride1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-640-01EA - Each10135-640b420df7f-388e-412e-8367-9047ea4dfb8612018-05-09
10135-640-05EA - Each10135-64059240efb-a0cc-4285-86ae-5f82e969ef2812018-05-09
10135-640-10EA - Each10135-6400931881e-8018-4935-b429-8c61b06b9cc512018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-640OXYBUTYNIN CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 3 package rows20191112_97f3f988-6bf1-453c-9be2-6671119a6f0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN97f3f988-6bf1-453c-9be2-6671119a6f0b2
863664oxybutynin chloride 5 MG Oral TabletSCD97f3f988-6bf1-453c-9be2-6671119a6f0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-640-0110135064001100 in 1 BOTTLEHistorical
10135-640-0510135064005500 in 1 BOTTLEHistorical
10135-640-10101350640101000 in 1 BOTTLEHistorical