Oxybutynin Chloride

Product NDC
71335-2121
11-digit product format
713352121
Labeler code
71335
Product ID
71335-2121_9b4a7465-5a1a-4474-b2d3-9befee70bc1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206121
Marketing category
ANDA
Marketing start
2016-09-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2121-1Oxybutynin ChlorideExtended Release30 in 1 BOTTLETABLET, EXTENDED RELEASE30102
71335-2121-2Oxybutynin ChlorideExtended Release18 in 1 BOTTLETABLET, EXTENDED RELEASE18102
71335-2121-3Oxybutynin ChlorideExtended Release90 in 1 BOTTLETABLET, EXTENDED RELEASE90102
71335-2121-4Oxybutynin ChlorideExtended Release60 in 1 BOTTLETABLET, EXTENDED RELEASE60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2121OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240526_169d6d58-8887-4bdd-95bd-873d1f049eaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN169d6d58-8887-4bdd-95bd-873d1f049eaa102
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD169d6d58-8887-4bdd-95bd-873d1f049eaa102
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY169d6d58-8887-4bdd-95bd-873d1f049eaa102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2121-17133521210130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2121-1) 2022-06-200000-00-00NoNoCurrent
71335-2121-27133521210218 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2121-2) 2022-06-200000-00-00NoNoCurrent
71335-2121-37133521210390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2121-3) 2022-06-200000-00-00NoNoCurrent
71335-2121-47133521210460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2121-4) 2022-06-200000-00-00NoNoCurrent