FDA.reportPublic FDA data

OXYBUTYNIN CHLORIDE

Product NDC
71335-1014
11-digit product format
713351014
Labeler code
71335
Product ID
71335-1014_d8012174-1a1c-46d9-9e97-094e9462a1f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209025
Marketing category
ANDA
Marketing start
2018-02-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXYBUTYNIN CHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863664

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1014-1OXYBUTYNIN CHLORIDE30 in 1 BOTTLETABLET305
71335-1014-2OXYBUTYNIN CHLORIDE100 in 1 BOTTLETABLET1005
71335-1014-3OXYBUTYNIN CHLORIDE20 in 1 BOTTLETABLET205
71335-1014-4OXYBUTYNIN CHLORIDE60 in 1 BOTTLETABLET605
71335-1014-5OXYBUTYNIN CHLORIDE90 in 1 BOTTLETABLET905
71335-1014-6OXYBUTYNIN CHLORIDE42 in 1 BOTTLETABLET425
71335-1014-7OXYBUTYNIN CHLORIDE15 in 1 BOTTLETABLET155
71335-1014-8OXYBUTYNIN CHLORIDE180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1014OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240823_f26e590d-956e-493b-a6ac-6056aeeaf411.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNf26e590d-956e-493b-a6ac-6056aeeaf4115
863664oxybutynin chloride 5 MG Oral TabletSCDf26e590d-956e-493b-a6ac-6056aeeaf4115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1014-17133510140130 TABLET in 1 BOTTLE (71335-1014-1) 30 tablet2018-11-210000-00-00NoNoCurrent
71335-1014-271335101402100 TABLET in 1 BOTTLE (71335-1014-2) 100 tablet2024-08-090000-00-00NoNoCurrent
71335-1014-37133510140320 TABLET in 1 BOTTLE (71335-1014-3) 20 tablet2024-08-090000-00-00NoNoCurrent
71335-1014-47133510140460 TABLET in 1 BOTTLE (71335-1014-4) 60 tablet2024-08-090000-00-00NoNoCurrent
71335-1014-57133510140590 TABLET in 1 BOTTLE (71335-1014-5) 90 tablet2024-08-090000-00-00NoNoCurrent
71335-1014-67133510140642 TABLET in 1 BOTTLE (71335-1014-6) 42 tablet2024-08-090000-00-00NoNoCurrent
71335-1014-77133510140715 TABLET in 1 BOTTLE (71335-1014-7) 15 tablet2024-08-090000-00-00NoNoCurrent
71335-1014-871335101408180 TABLET in 1 BOTTLE (71335-1014-8) 180 tablet2024-08-090000-00-00NoNoCurrent