oxybutynin

Product NDC
68382-255
11-digit product format
683820255
Labeler code
68382
Product ID
68382-255_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
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202332-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26
A202332-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26
A202332-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2017-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202332-001AB
A202332-002AB
A202332-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2017-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2017-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202332-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202332-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202332-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202332-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202332-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202332-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202332-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202332-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202332-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202332-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202332-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202332-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202332-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202332-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202332-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202332-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202332-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202332-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202332-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202332-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202332-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202332-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202332-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202332-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202332-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202332-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202332-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202332-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202332-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202332-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202332-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202332-001AB18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L9F3D9RENQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863619Internal RxNorm lookup
863628Internal RxNorm lookup
863636Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c042bf06-79a3-4dc7-ae05-3ef3cfae9d44Available on FDA.report

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
68382-255-01oxybutynin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
68382-255-05oxybutynin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5007
68382-255-06oxybutynin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307
68382-255-14oxybutynin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE607
68382-255-16oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE907
68382-255-30oxybutynin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107
68382-255-77oxybutynin10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-255-01EA - Each68382-255602aa4ca-2cb5-4f50-9f05-078eebd890bf12018-03-08
68382-255-05EA - Each68382-255a142c606-36f9-47c4-b0b9-db159dcef7af12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-255OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 7 package rows20231110_c042bf06-79a3-4dc7-ae05-3ef3cfae9d44.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxybutyninOXYBUTYNINZydus Lifesciences Limitedf405a774-bd91-4513-b7c7-c44f0596d9882024-12-03Exact identifier
application applno (ANDA): 202332
application number: ANDA202332
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsec4fd95f-16dc-4acf-b560-b67b7aaef08b2024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202332
application number: ANDA202332
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsed10f0c9-23d6-4ded-b17f-ed474632a9652024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202332
application number: ANDA202332
oxybutyninOXYBUTYNINZydus Pharmaceuticals USA Inc.c042bf06-79a3-4dc7-ae05-3ef3cfae9d442023-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202332
application number: ANDA202332
ndc (product): 68382-255
oxybutyninOXYBUTYNINA-S Medication Solutions1f95920c-5dc2-44e4-b61d-b2c5e05390ba2023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202332
application number: ANDA202332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNed10f0c9-23d6-4ded-b17f-ed474632a96511
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDed10f0c9-23d6-4ded-b17f-ed474632a96511
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYed10f0c9-23d6-4ded-b17f-ed474632a96511
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
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN4ef97dd9-77a1-49a3-896b-ea810efbbd533
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD4ef97dd9-77a1-49a3-896b-ea810efbbd533
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY4ef97dd9-77a1-49a3-896b-ea810efbbd533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-255-0168382025501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-01) 2017-08-100000-00-00NoNoCurrent
68382-255-0568382025505500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05) 2017-08-100000-00-00NoNoCurrent
68382-255-066838202550630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06) 2017-08-100000-00-00NoNoCurrent
68382-255-146838202551460 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14) 2017-08-100000-00-00NoNoCurrent
68382-255-166838202551690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16) 2017-08-100000-00-00NoNoCurrent
68382-255-306838202553010 in 1 BLISTER PACKHistorical
68382-255-776838202557710 BLISTER PACK in 1 CARTON (68382-255-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30) 10 blister pack2017-08-100000-00-00NoNoCurrent