FDA.reportPublic FDA data

OXYBUTYNIN CHLORIDE

Product NDC
63629-5484
11-digit product format
636295484
Labeler code
63629
Product ID
63629-5484_70b1403e-beae-4720-8028-4ee34481f74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076745
Marketing category
ANDA
Marketing start
2007-05-11
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
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
63629-5484-12020-01-31C16284748780-19d75b9cf-d739-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 for oral use Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5484-1OXYBUTYNIN CHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5484OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001Legacy NDC, 1 package rows20150325_b9090682-ea78-4f3e-9b07-c97d119d264b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNb9090682-ea78-4f3e-9b07-c97d119d264b1001
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDb9090682-ea78-4f3e-9b07-c97d119d264b1001
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYb9090682-ea78-4f3e-9b07-c97d119d264b1001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63629-5484-16362954840130 in 1 BOTTLEHistorical