Oxybutynin Chloride

Product NDC
70934-529
11-digit product format
709340529
Labeler code
70934
Product ID
70934-529_a967486a-9732-7c4f-e053-2a95a90aae93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA209823
Marketing category
ANDA
Marketing start
2020-01-30
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
2021-12-31
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
70934-529-302022-01-28C16284748780-1d6a99b39-958d-a426-e053-dadaa90af4c2Oxybutynin Chloride Tablets, USP 5 mg Rx only
70934-529-602022-01-28C16284748780-1d6a99b39-958d-a426-e053-dadaa90af4c2Oxybutynin Chloride Tablets, USP 5 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-529-30Oxybutynin Chloride30 in 1 BOTTLE, PLASTICTABLET301
70934-529-60Oxybutynin Chloride60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-529OXYBUTYNIN CHLORIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 2 package rows20200929_a966bf93-9053-13df-e053-2a95a90a075a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNa966bf93-9053-13df-e053-2a95a90a075a1
863664oxybutynin chloride 5 MG Oral TabletSCDa966bf93-9053-13df-e053-2a95a90a075a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-529-307093405293030 TABLET in 1 BOTTLE, PLASTIC (70934-529-30) 30 tablet2020-01-300000-00-00NoNoCurrent
70934-529-607093405296060 TABLET in 1 BOTTLE, PLASTIC (70934-529-60) 60 tablet2020-02-040000-00-00NoNoCurrent