FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
71335-0519
11-digit product format
713350519
Labeler code
71335
Product ID
71335-0519_46064d9f-6de0-4f4c-8b9a-70fdd5e4af72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071655
Marketing category
ANDA
Marketing start
1990-09-30
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
71335-0519-1Oxybutynin Chloride30 in 1 BOTTLETABLET305
71335-0519-2Oxybutynin Chloride100 in 1 BOTTLETABLET1005
71335-0519-3Oxybutynin Chloride20 in 1 BOTTLETABLET205
71335-0519-4Oxybutynin Chloride60 in 1 BOTTLETABLET605
71335-0519-5Oxybutynin Chloride90 in 1 BOTTLETABLET905
71335-0519-6Oxybutynin Chloride42 in 1 BOTTLETABLET425
71335-0519-7Oxybutynin Chloride15 in 1 BOTTLETABLET155
71335-0519-8Oxybutynin Chloride180 in 1 BOTTLETABLET1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0519-1EA - Each71335-05197655c230-3296-465f-8f79-c339a22e8e1812018-03-08
71335-0519-2EA - Each71335-0519e74ee4ca-7d14-4803-a3d8-b3f44c13e5e412018-03-08
71335-0519-3EA - Each71335-0519e36df579-dcf3-4520-9b23-9a91193fbc5d12018-03-08
71335-0519-4EA - Each71335-0519f7648e39-29d2-4ebf-ba1e-be0c49fc679e12018-03-08
71335-0519-5EA - Each71335-0519c6f7c861-c898-41e1-88b9-dff7feac967b12018-03-08
71335-0519-6EA - Each71335-051945809d36-bdaa-4d19-90b9-12d4699aa35912018-03-08
71335-0519-7EA - Each71335-05196de9aba0-a655-41fa-af0a-cfc3bd5d6aa412018-03-08
71335-0519-8EA - Each71335-0519e4c74e6b-9b48-431d-8619-60827d0500e212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0519OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20241004_246d2f79-8ab5-4023-9068-1451b695ac16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN246d2f79-8ab5-4023-9068-1451b695ac165
863664oxybutynin chloride 5 MG Oral TabletSCD246d2f79-8ab5-4023-9068-1451b695ac165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0519-17133505190130 TABLET in 1 BOTTLE (71335-0519-1) 30 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-271335051902100 TABLET in 1 BOTTLE (71335-0519-2) 100 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-37133505190320 TABLET in 1 BOTTLE (71335-0519-3) 20 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-47133505190460 TABLET in 1 BOTTLE (71335-0519-4) 60 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-57133505190590 TABLET in 1 BOTTLE (71335-0519-5) 90 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-67133505190642 TABLET in 1 BOTTLE (71335-0519-6) 42 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-77133505190715 TABLET in 1 BOTTLE (71335-0519-7) 15 tablet2008-07-220000-00-00NoNoCurrent
71335-0519-871335051908180 TABLET in 1 BOTTLE (71335-0519-8) 180 tablet2008-07-220000-00-00NoNoCurrent