FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
10702-201
11-digit product format
107020201
Labeler code
10702
Product ID
10702-201_289ec3ce-2fb1-608b-e063-6394a90a4a7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA209335
Marketing category
ANDA
Marketing start
2017-12-22
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
10702-201-01Oxybutynin Chloride100 in 1 BOTTLE, PLASTICTABLET1008
10702-201-10Oxybutynin Chloride1000 in 1 BOTTLE, PLASTICTABLET10008
10702-201-50Oxybutynin Chloride500 in 1 BOTTLE, PLASTICTABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-201-01EA - Each10702-2017c0c70e2-2045-441a-96aa-7349b00cab7612018-02-20
10702-201-10EA - Each10702-201bc1919eb-c6af-4e8e-aad4-dbc502560d8012018-02-20
10702-201-50EA - Each10702-201b7445284-a886-4d44-90dc-623ac0313bcd12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-201OXYBUTYNIN CHLORIDE TABLET [KVK-TECH, INC.]8Current NDC, Legacy NDC, 3 package rows20241212_f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0c021aad-97a3-4404-a11e-cdd2ec731c6b15
863664oxybutynin chloride 5 MG Oral TabletSCD0c021aad-97a3-4404-a11e-cdd2ec731c6b15
863664oxyBUTYnin chloride 5 MG Oral TabletPSN9c8ced4b-94de-4df8-bea3-b42b8846b76914
863664oxybutynin chloride 5 MG Oral TabletSCD9c8ced4b-94de-4df8-bea3-b42b8846b76914
863664oxyBUTYnin chloride 5 MG Oral TabletPSN39a2d144-0c10-4aec-9fa4-0adc24b332eb11
863664oxybutynin chloride 5 MG Oral TabletSCD39a2d144-0c10-4aec-9fa4-0adc24b332eb11
863664oxyBUTYnin chloride 5 MG Oral TabletPSN1a08a16a-f16d-4ef1-95bb-6943bcae07379
863664oxybutynin chloride 5 MG Oral TabletSCD1a08a16a-f16d-4ef1-95bb-6943bcae07379
863664oxyBUTYnin chloride 5 MG Oral TabletPSNf99fdfe8-a980-4a72-bc99-aa2ce0bdfd868
863664oxybutynin chloride 5 MG Oral TabletSCDf99fdfe8-a980-4a72-bc99-aa2ce0bdfd868
863664oxyBUTYnin chloride 5 MG Oral TabletPSNf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb5
863664oxybutynin chloride 5 MG Oral TabletSCDf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb5
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0e002fe8-fa3f-4a7d-84df-0c6e031e6ae44
863664oxybutynin chloride 5 MG Oral TabletSCD0e002fe8-fa3f-4a7d-84df-0c6e031e6ae44
863664oxyBUTYnin chloride 5 MG Oral TabletPSN13a79659-a181-6a61-e063-6294a90ae0342
863664oxybutynin chloride 5 MG Oral TabletSCD13a79659-a181-6a61-e063-6294a90ae0342
863664oxyBUTYnin chloride 5 MG Oral TabletPSN8189da24-31df-428f-bae5-b249779a90571
863664oxybutynin chloride 5 MG Oral TabletSCD8189da24-31df-428f-bae5-b249779a90571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-201-0110702020101100 TABLET in 1 BOTTLE, PLASTIC (10702-201-01) 100 tablet2017-12-220000-00-00NoNoCurrent
10702-201-10107020201101000 TABLET in 1 BOTTLE, PLASTIC (10702-201-10) 1000 tablet2017-12-220000-00-00NoNoCurrent
10702-201-5010702020150500 TABLET in 1 BOTTLE, PLASTIC (10702-201-50) 500 tablet2017-12-220000-00-00NoNoCurrent