FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
23155-810
11-digit product format
231550810
Labeler code
23155
Product ID
23155-810_e12456ec-640f-45a5-b78a-66e22c36d24a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA208165
Marketing category
ANDA
Marketing start
2022-01-31
Marketing end
2027-08-31
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride

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
23155-810-01Oxybutynin Chloride100 in 1 BOTTLETABLET1003
23155-810-05Oxybutynin Chloride500 in 1 BOTTLETABLET5003
23155-810-10Oxybutynin Chloride1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-810-01EA - Each23155-810aea80ed2-a8eb-4dc8-8cdc-ab4d5666d6e612022-07-06
23155-810-05EA - Each23155-8107d803758-d9f6-433e-a86a-2f82cb7bed2d12022-07-06
23155-810-10EA - Each23155-8100d76897a-5a67-43f7-81c2-d551e716daf712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-810OXYBUTYNIN CHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 3 package rows20220131_9a551ec5-7e80-47c9-a7b9-f458c1478174.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN9a551ec5-7e80-47c9-a7b9-f458c14781743
863664oxybutynin chloride 5 MG Oral TabletSCD9a551ec5-7e80-47c9-a7b9-f458c14781743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-810-0123155081001100 TABLET in 1 BOTTLE (23155-810-01) 100 tablet2022-01-312027-07-31NoNoCurrent
23155-810-0523155081005500 TABLET in 1 BOTTLE (23155-810-05) 500 tablet2022-01-312027-08-31NoNoCurrent
23155-810-10231550810101000 TABLET in 1 BOTTLE (23155-810-10) 1000 tablet2022-01-312027-07-31NoNoCurrent