FDA.reportPublic FDA data

oxybutynin chloride

Product NDC
50090-5822
11-digit product format
500905822
Labeler code
50090
Product ID
50090-5822_0266855a-dbf4-4258-92c5-51e8c0a0738c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207138
Marketing category
ANDA
Marketing start
2016-12-14
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
Rxcui863636

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5822-02023-02-06C16284748780-1f386c64a-021b-0266-e053-dadaa90a7c1aThese 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
50090-5822-02023-01-30C16284748780-1f386c64a-021b-0266-e053-dadaa90a7c1aThese 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
50090-5822-0oxybutynin chloride90 in 1 BOTTLETABLET, EXTENDED RELEASE909
50090-5822-1oxybutynin chloride30 in 1 BOTTLETABLET, EXTENDED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5822-0EA - Each50090-58229e4bd8c8-8fa8-438b-81dc-d063777b137312022-07-06
50090-5822-1EA - Each50090-5822ba2789fd-cbf9-4325-bb70-ee7367865e0612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5822OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240604_7593becc-250f-4d25-8401-a9f72f3f5ad4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN7593becc-250f-4d25-8401-a9f72f3f5ad49
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD7593becc-250f-4d25-8401-a9f72f3f5ad49
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY7593becc-250f-4d25-8401-a9f72f3f5ad49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5822-05009058220090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5822-0) 2021-10-200000-00-00NoNoCurrent
50090-5822-15009058220130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5822-1) 2023-07-19NoNoCurrent