Oxybutynin Chloride

Product NDC
55154-2632
11-digit product format
551542632
Labeler code
55154
Product ID
55154-2632_10f1f9c9-8e11-4c53-889c-a6a6875c202f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA209823
Marketing category
ANDA
Marketing start
2024-10-21
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
55154-2632-0Oxybutynin Chloride1 in 1 BLISTER PACKTABLET13
55154-2632-0Oxybutynin Chloride10 in 1 BAGTABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2632OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20250108_8455b543-81ce-4522-ae9b-8396f944945c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN8455b543-81ce-4522-ae9b-8396f944945c3
863664oxybutynin chloride 5 MG Oral TabletSCD8455b543-81ce-4522-ae9b-8396f944945c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2632-05515426320010 BLISTER PACK in 1 BAG (55154-2632-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2024-10-21NoNoCurrent