FDA.reportPublic FDA data

OXYBUTYNIN CHLORIDE

Product NDC
50090-6638
11-digit product format
500906638
Labeler code
50090
Product ID
50090-6638_55b5448c-fbe7-440c-a4b0-5b5898fbae25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209025
Marketing category
ANDA
Marketing start
2018-02-01
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
50090-6638-0OXYBUTYNIN CHLORIDE30 in 1 BOTTLETABLET305
50090-6638-1OXYBUTYNIN CHLORIDE100 in 1 BOTTLETABLET1005
50090-6638-3OXYBUTYNIN CHLORIDE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6638-0EA - Each50090-663886bf1dea-ff13-4d9e-98fe-7a7e96d33b5c12023-10-16
50090-6638-1EA - Each50090-6638869c5dcc-44fb-43c8-b1c6-83a32fc49c1812024-02-14
50090-6638-3EA - Each50090-6638a9ba9b6e-cabc-4aaf-80bd-6c6ad89c28e812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6638OXYBUTYNIN CHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20240105_0697b3cf-b146-47c0-b5a5-5905ae8d1c97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0697b3cf-b146-47c0-b5a5-5905ae8d1c975
863664oxybutynin chloride 5 MG Oral TabletSCD0697b3cf-b146-47c0-b5a5-5905ae8d1c975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6638-05009066380030 TABLET in 1 BOTTLE (50090-6638-0) 30 tablet2023-08-29NoNoCurrent
50090-6638-150090663801100 TABLET in 1 BOTTLE (50090-6638-1) 100 tablet2023-08-29NoNoCurrent
50090-6638-35009066380390 TABLET in 1 BOTTLE (50090-6638-3) 90 tablet2023-08-29NoNoCurrent