Oxybutynin Chloride

Product NDC
51655-665
11-digit product format
516550665
Labeler code
51655
Product ID
51655-665_4950ae3a-d3c8-b948-e063-6394a90afa44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA209823
Marketing category
ANDA
Marketing start
2022-08-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2027-12-31

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
51655-665-25Oxybutynin Chloride60 in 1 BOTTLE, PLASTICTABLET604
51655-665-52Oxybutynin Chloride30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-665OXYBUTYNIN CHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241228_f330b7a0-bbe0-0f00-e053-2a95a90a37b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNf330b7a0-bbe0-0f00-e053-2a95a90a37b84
863664oxybutynin chloride 5 MG Oral TabletSCDf330b7a0-bbe0-0f00-e053-2a95a90a37b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-665-255165506652560 TABLET in 1 BOTTLE, PLASTIC (51655-665-25) 60 tablet2022-12-16NoNoCurrent
51655-665-525165506655230 TABLET in 1 BOTTLE, PLASTIC (51655-665-52) 30 tablet2022-08-09NoNoCurrent