FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
42291-634
11-digit product format
422910634
Labeler code
42291
Product ID
42291-634_46143c62-4276-2b49-e063-6294a90ae1aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA078503
Marketing category
ANDA
Marketing start
2016-03-09
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 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
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619, 863628, 863636

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-634-01Oxybutynin ChlorideExtended Release100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
42291-634-50Oxybutynin ChlorideExtended Release500 in 1 BOTTLETABLET, EXTENDED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-634-01EA - Each42291-6347efb368b-c5d4-4b4e-a956-1f7ce334a32212016-04-04
42291-634-50EA - Each42291-63473e1b6e9-de9c-4f5d-af62-d409011cbae712016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-634OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVKARE]6Current NDC, Legacy NDC, 2 package rows20220114_94471401-a516-0fe7-ec9c-447dd2bee972.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN94471401-a516-0fe7-ec9c-447dd2bee9727
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN94471401-a516-0fe7-ec9c-447dd2bee9727
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN94471401-a516-0fe7-ec9c-447dd2bee9727
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD94471401-a516-0fe7-ec9c-447dd2bee9727
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD94471401-a516-0fe7-ec9c-447dd2bee9727
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD94471401-a516-0fe7-ec9c-447dd2bee9727
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY94471401-a516-0fe7-ec9c-447dd2bee9727
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY94471401-a516-0fe7-ec9c-447dd2bee9727
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY94471401-a516-0fe7-ec9c-447dd2bee9727
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-634-0142291063401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01) 2016-03-090000-00-00NoNoCurrent
42291-634-5042291063450500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50) 2016-03-090000-00-00NoNoCurrent