FDA.reportPublic FDA data

oxybutynin

Product NDC
70771-1086
11-digit product format
707711086
Labeler code
70771
Product ID
70771-1086_e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA202332
Marketing category
ANDA
Marketing start
2017-08-10
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
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
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
70771-1086-1oxybutynin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
70771-1086-2oxybutynin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE108
70771-1086-3oxybutynin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
70771-1086-4oxybutynin10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE108
70771-1086-5oxybutynin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
70771-1086-6oxybutynin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
70771-1086-9oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1086OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20241206_f405a774-bd91-4513-b7c7-c44f0596d988.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNf405a774-bd91-4513-b7c7-c44f0596d9888
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSNf405a774-bd91-4513-b7c7-c44f0596d9888
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNf405a774-bd91-4513-b7c7-c44f0596d9888
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDf405a774-bd91-4513-b7c7-c44f0596d9888
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCDf405a774-bd91-4513-b7c7-c44f0596d9888
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDf405a774-bd91-4513-b7c7-c44f0596d9888
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYf405a774-bd91-4513-b7c7-c44f0596d9888
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSYf405a774-bd91-4513-b7c7-c44f0596d9888
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYf405a774-bd91-4513-b7c7-c44f0596d9888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1086-170771108601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-1) 2017-08-100000-00-00NoNoCurrent
70771-1086-27077110860210 in 1 BLISTER PACKHistorical
70771-1086-37077110860330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-3) 2017-08-100000-00-00NoNoCurrent
70771-1086-47077110860410 BLISTER PACK in 1 CARTON (70771-1086-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1086-2) 10 blister pack2017-08-100000-00-00NoNoCurrent
70771-1086-570771108605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-5) 2017-08-100000-00-00NoNoCurrent
70771-1086-67077110860660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-6) 2017-08-100000-00-00NoNoCurrent
70771-1086-97077110860990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-9) 2017-08-100000-00-00NoNoCurrent