FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
50090-6673
11-digit product format
500906673
Labeler code
50090
Product ID
50090-6673_92090e0c-c4f0-420d-b3cf-cf54fcf219ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206121
Marketing category
ANDA
Marketing start
2016-09-27
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
Brand name suffix
Extended Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619

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
50090-6673-0Oxybutynin ChlorideExtended Release90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6673-0EA - Each50090-66733614cf84-dc0d-4434-9b71-1389c4e0a33212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230907_3688227b-7655-40ca-b34b-073a39fd60f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN3688227b-7655-40ca-b34b-073a39fd60f43
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD3688227b-7655-40ca-b34b-073a39fd60f43
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY3688227b-7655-40ca-b34b-073a39fd60f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6673-05009066730090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6673-0) 2023-09-01NoNoHistorical