FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
50090-4622
11-digit product format
500904622
Labeler code
50090
Product ID
50090-4622_b50d393a-fbbf-4184-95a8-aadb8b0468f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209335
Marketing category
ANDA
Marketing start
2017-12-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4622-02023-02-06C16284748780-1f386c649-d7f1-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-12023-02-06C16284748780-1f386c649-d7f1-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-32023-02-06C16284748780-1f386c649-d7f1-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-02023-01-30C16284748780-1f386c649-d7f1-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-12023-01-30C16284748780-1f386c649-d7f1-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-32023-01-30C16284748780-1f386c649-d7f1-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4622-0Oxybutynin Chloride30 in 1 BOTTLETABLET3011
50090-4622-1Oxybutynin Chloride100 in 1 BOTTLETABLET10011
50090-4622-3Oxybutynin Chloride90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4622-0EA - Each50090-4622341581ec-a389-4c39-8913-c2b1c57eb2e712022-12-07
50090-4622-1EA - Each50090-462279095bee-3fb1-4c38-be46-3f6c2720332e12022-12-07
50090-4622-3EA - Each50090-4622f9e87985-b8f4-4b6d-9ca1-73269e326b7312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4622OXYBUTYNIN CHLORIDE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20240604_39a2d144-0c10-4aec-9fa4-0adc24b332eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN39a2d144-0c10-4aec-9fa4-0adc24b332eb11
863664oxybutynin chloride 5 MG Oral TabletSCD39a2d144-0c10-4aec-9fa4-0adc24b332eb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4622-05009046220030 TABLET in 1 BOTTLE (50090-4622-0) 30 tablet2019-10-180000-00-00NoNoCurrent
50090-4622-150090462201100 TABLET in 1 BOTTLE (50090-4622-1) 100 tablet2019-10-180000-00-00NoNoCurrent
50090-4622-35009046220390 TABLET in 1 BOTTLE (50090-4622-3) 90 tablet2019-10-180000-00-00NoNoCurrent