FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
62175-270
11-digit product format
621750270
Labeler code
62175
Product ID
62175-270_72bbc7a8-711b-47a6-8152-9409f4068929
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA078503
Marketing category
ANDA
Marketing start
2009-03-01
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
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE5 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
62175-270-37Oxybutynin ChlorideExtended Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10042
62175-270-41Oxybutynin ChlorideExtended Release500 in 1 BOTTLETABLET, EXTENDED RELEASE50042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-270-37EA - Each62175-2703253b735-93a6-4b5c-ad98-d01cbaebeb8412012-07-24
62175-270-41EA - Each62175-27061ba9a72-489f-4b7c-9586-50e8ee74181512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
MANNITOLINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-270OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]42Current NDC, Legacy NDC, 2 package rows20230629_c5950dba-d92b-46a0-993f-af9f9ddb52bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSNc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNc5950dba-d92b-46a0-993f-af9f9ddb52bf42
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDc5950dba-d92b-46a0-993f-af9f9ddb52bf42
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCDc5950dba-d92b-46a0-993f-af9f9ddb52bf42
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSYc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN0c71bdfb-01db-49ac-a8e9-0037df0d24af12
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD0c71bdfb-01db-49ac-a8e9-0037df0d24af12
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN242b4766-bc2b-0073-d72d-1bf879bbee248
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN242b4766-bc2b-0073-d72d-1bf879bbee248
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN242b4766-bc2b-0073-d72d-1bf879bbee248
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD242b4766-bc2b-0073-d72d-1bf879bbee248
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD242b4766-bc2b-0073-d72d-1bf879bbee248
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD242b4766-bc2b-0073-d72d-1bf879bbee248
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY242b4766-bc2b-0073-d72d-1bf879bbee248
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY242b4766-bc2b-0073-d72d-1bf879bbee248
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY242b4766-bc2b-0073-d72d-1bf879bbee248
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
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN9b875869-2fe6-4274-bb1a-3a1406616ce76
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD9b875869-2fe6-4274-bb1a-3a1406616ce76
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY9b875869-2fe6-4274-bb1a-3a1406616ce76
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNe985e201-2fb3-4781-9790-a1a3db1ae2a11
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDe985e201-2fb3-4781-9790-a1a3db1ae2a11
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYe985e201-2fb3-4781-9790-a1a3db1ae2a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-270-326217502703230 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-270-32) 2009-03-010000-00-00NoNoCurrent
62175-270-3762175027037100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-270-37) 2009-03-010000-00-00NoNoCurrent
62175-270-4162175027041500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-270-41) 2009-03-010000-00-00NoNoCurrent
62175-270-43621750270431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-270-43) 2009-03-010000-00-00NoNoCurrent