FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
72888-031
11-digit product format
728880031
Labeler code
72888
Product ID
72888-031_48596af5-29b7-ab6c-e063-6394a90a1276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA214415
Marketing category
ANDA
Marketing start
2020-10-27
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
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, 863628, 863636

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
72888-031-01Oxybutynin Chloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1008
72888-031-05Oxybutynin Chloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-031-01EA - Each72888-03136e5672f-adb4-4002-91e3-acb9c945297812021-06-02
72888-031-05EA - Each72888-03186aa3b1b-6ca8-47d0-ad83-2e2e4e0ea85c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-031OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [ADVAGEN PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20240713_7bd31561-4c76-4c6b-819b-492549886673.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN7bd31561-4c76-4c6b-819b-4925498866738
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN7bd31561-4c76-4c6b-819b-4925498866738
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN7bd31561-4c76-4c6b-819b-4925498866738
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD7bd31561-4c76-4c6b-819b-4925498866738
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD7bd31561-4c76-4c6b-819b-4925498866738
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD7bd31561-4c76-4c6b-819b-4925498866738
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY7bd31561-4c76-4c6b-819b-4925498866738
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY7bd31561-4c76-4c6b-819b-4925498866738
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY7bd31561-4c76-4c6b-819b-4925498866738

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-031-0172888003101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-031-01) 2020-10-270000-00-00NoNoCurrent
72888-031-0572888003105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-031-05) 2024-07-10NoNoHistorical