Oxybutynin Chloride

Product NDC
71335-1690
11-digit product format
713351690
Labeler code
71335
Product ID
71335-1690_b96b1e58-04f2-40be-9b7d-03209475cc2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211655
Marketing category
ANDA
Marketing start
2019-02-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2027-12-31

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1690-1Oxybutynin Chloride30 in 1 BOTTLETABLET, EXTENDED RELEASE305
71335-1690-2Oxybutynin Chloride18 in 1 BOTTLETABLET, EXTENDED RELEASE185
71335-1690-3Oxybutynin Chloride90 in 1 BOTTLETABLET, EXTENDED RELEASE905
71335-1690-4Oxybutynin Chloride60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1690OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 4 package rows20240524_a5965c8b-179d-4665-8a3b-324b693607ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNa5965c8b-179d-4665-8a3b-324b693607ee5
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDa5965c8b-179d-4665-8a3b-324b693607ee5
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYa5965c8b-179d-4665-8a3b-324b693607ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1690-17133516900130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-1) 2021-12-290000-00-00NoNoCurrent
71335-1690-27133516900218 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-2) 2021-12-290000-00-00NoNoCurrent
71335-1690-37133516900390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-3) 2020-08-110000-00-00NoNoCurrent
71335-1690-47133516900460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-4) 2021-12-290000-00-00NoNoCurrent