FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
50090-4658
11-digit product format
500904658
Labeler code
50090
Product ID
50090-4658_b48494fe-1175-45a8-843b-364cb539f1fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204010
Marketing category
ANDA
Marketing start
2015-11-02
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-4658-02023-01-30C16284748780-1f386c64a-394f-0266-e053-dadaa90a7c1aThese 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, for oral use Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4658-0Oxybutynin Chloride90 in 1 BOTTLETABLET, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4658-0EA - Each50090-4658a2e147f7-045b-4911-84fa-ca15849fd3ad12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4658OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Legacy NDC, 1 package rows20210615_e7c7c1b4-a5c8-40cc-832c-76d79904b8ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNe7c7c1b4-a5c8-40cc-832c-76d79904b8ef6
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDe7c7c1b4-a5c8-40cc-832c-76d79904b8ef6
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYe7c7c1b4-a5c8-40cc-832c-76d79904b8ef6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4658-05009046580090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4658-0) 2019-10-280000-00-00NoNoCurrent