FDA.reportPublic FDA data

oxybutynin

Product NDC
68382-256
11-digit product format
683820256
Labeler code
68382
Product ID
68382-256_f54e4d4e-91be-4e10-a446-57ed5e1843a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA202332
Marketing category
ANDA
Marketing start
2017-08-10
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
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
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
68382-256-01oxybutynin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
68382-256-05oxybutynin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5007
68382-256-06oxybutynin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307
68382-256-14oxybutynin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE607
68382-256-16oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE907
68382-256-30oxybutynin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107
68382-256-77oxybutynin10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-256-01EA - Each68382-256776d3361-0a48-4302-8f10-9fb57065cfff12018-03-08
68382-256-05EA - Each68382-25625a49211-2204-4e59-97d7-95709b03d7d612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-256OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 7 package rows20231110_c042bf06-79a3-4dc7-ae05-3ef3cfae9d44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNec4fd95f-16dc-4acf-b560-b67b7aaef08b9
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDec4fd95f-16dc-4acf-b560-b67b7aaef08b9
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYec4fd95f-16dc-4acf-b560-b67b7aaef08b9
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSNc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCDc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSYc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYc042bf06-79a3-4dc7-ae05-3ef3cfae9d447
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN1f95920c-5dc2-44e4-b61d-b2c5e05390ba5
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD1f95920c-5dc2-44e4-b61d-b2c5e05390ba5
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY1f95920c-5dc2-44e4-b61d-b2c5e05390ba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-256-0168382025601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-256-01) 2017-08-100000-00-00NoNoCurrent
68382-256-0568382025605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-256-05) 2017-08-100000-00-00NoNoCurrent
68382-256-066838202560630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-256-06) 2017-08-100000-00-00NoNoCurrent
68382-256-146838202561460 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-256-14) 2017-08-100000-00-00NoNoCurrent
68382-256-166838202561690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-256-16) 2017-08-100000-00-00NoNoCurrent
68382-256-306838202563010 in 1 BLISTER PACKHistorical
68382-256-776838202567710 BLISTER PACK in 1 CARTON (68382-256-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-256-30) 10 blister pack2017-08-100000-00-00NoNoCurrent