FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
50090-6966
11-digit product format
500906966
Labeler code
50090
Product ID
50090-6966_152bdcf5-866b-47c5-a491-c6595c2bc4ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209823
Marketing category
ANDA
Marketing start
2017-11-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6966-0Oxybutynin Chloride30 in 1 BOTTLETABLET301
50090-6966-1Oxybutynin Chloride100 in 1 BOTTLETABLET1001
50090-6966-3Oxybutynin Chloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6966-0EA - Each50090-696644705144-ed02-4531-9c9d-5c30f717599812024-02-14
50090-6966-1EA - Each50090-69665d92bdf2-a11a-4995-a513-8a44a3729e1512024-02-14
50090-6966-3EA - Each50090-69666e5858f9-faa9-4f66-8a7f-4bdd47b2886b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6966OXYBUTYNIN CHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231228_5e3b454b-6d3c-418b-8ac2-b0e17f018bbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN5e3b454b-6d3c-418b-8ac2-b0e17f018bbf1
863664oxybutynin chloride 5 MG Oral TabletSCD5e3b454b-6d3c-418b-8ac2-b0e17f018bbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6966-05009069660030 TABLET in 1 BOTTLE (50090-6966-0) 30 tablet2023-12-21NoNoCurrent
50090-6966-150090696601100 TABLET in 1 BOTTLE (50090-6966-1) 100 tablet2023-12-21NoNoCurrent
50090-6966-35009069660390 TABLET in 1 BOTTLE (50090-6966-3) 90 tablet2023-12-21NoNoCurrent