Oxybutynin Chloride

Product NDC
52817-260
11-digit product format
528170260
Labeler code
52817
Product ID
52817-260_edabf40d-d160-c14b-e053-2995a90af00d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA210125
Marketing category
ANDA
Marketing start
2019-01-01
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
52817-260-10Oxybutynin Chloride100 in 1 BOTTLE, PLASTICTABLET1005
52817-260-50Oxybutynin Chloride500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-260-10EA - Each52817-2601d4a8ac4-58ed-42cb-9ce7-b57d881b0c6912019-07-02
52817-260-50EA - Each52817-260917c322b-c07c-4ff0-993c-ed0fc5c8b10312019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-260OXYBUTYNIN CHLORIDE TABLET [TRUPHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20221118_7c497c6c-2448-2c80-e053-2991aa0ab8c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN7c497c6c-2448-2c80-e053-2991aa0ab8c75
863664oxybutynin chloride 5 MG Oral TabletSCD7c497c6c-2448-2c80-e053-2991aa0ab8c75
863664oxyBUTYnin chloride 5 MG Oral TabletPSN1e1c1043-e4c5-4a06-9cc1-45d4397746f43
863664oxybutynin chloride 5 MG Oral TabletSCD1e1c1043-e4c5-4a06-9cc1-45d4397746f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-260-1052817026010100 TABLET in 1 BOTTLE, PLASTIC (52817-260-10) 100 tablet2019-01-010000-00-00NoNoCurrent
52817-260-5052817026050500 TABLET in 1 BOTTLE, PLASTIC (52817-260-50) 500 tablet2019-01-010000-00-00NoNoCurrent