OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:18:46

Label at a glance#

Productoxybutynin
Active ingredientOXYBUTYNIN CHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oxybutynin chloride extended-release tablets USP, 5 mg

NDC 70771-1086-1

100 tablets

Rx   only

Oxybutynin chloride extended-release tablets
Oxybutynin chloride extended-release tablets

Oxybutynin chloride extended-release tablets USP, 10 mg

NDC 70771-1087-1

100 tablets

Rx   only

Oxybutynin chloride extended-release tablets
Oxybutynin chloride extended-release tablets

Oxybutynin chloride extended-release tablets USP, 15 mg

NDC 70771-1088-1

100 tablets

Rx   only

Oxybutynin chloride extended-release tablets
Oxybutynin chloride extended-release tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN8
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN8
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN8
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD8
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD8
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD8
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY8
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY8
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYBUTYNIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1087-1oxybutynin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
70771-1087-2oxybutynin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE108
70771-1087-3oxybutynin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
70771-1087-4oxybutynin10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE108
70771-1087-5oxybutynin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
70771-1087-6oxybutynin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
70771-1087-9oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908
70771-1088-1oxybutynin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
70771-1088-2oxybutynin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE108
70771-1088-3oxybutynin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
70771-1088-4oxybutynin10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE108
70771-1088-5oxybutynin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
70771-1088-6oxybutynin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
70771-1088-9oxybutynin90 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
70771-1087OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20241206_f405a774-bd91-4513-b7c7-c44f0596d988.zip
70771-1088OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20241206_f405a774-bd91-4513-b7c7-c44f0596d988.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26c2088c7a36db…
2026-10-15 13:18:302026-09A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26c2088c7a36db…
2026-10-15 13:18:302026-09A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2017-06-26c2088c7a36db…
2026-09-14 22:38:342026-08A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2684e616aacf4f…
2026-09-14 22:38:342026-08A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-2684e616aacf4f…
2026-09-14 22:38:342026-08A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2017-06-2684e616aacf4f…
2026-08-18 06:07:402026-07A202332-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07A202332-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2017-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07A202332-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALABRS2017-06-26caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A202332-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A202332-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A202332-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A202332-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202332-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202332-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202332-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202332-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202332-003AB1caaa826d4ba7…
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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxybutyninOXYBUTYNINZydus Lifesciences Limitedf405a774-bd91-4513-b7c7-c44f0596d9882024-12-03Exact identifier
ndc (package): 70771-1086-1
ndc (package): 70771-1087-3
ndc (package): 70771-1088-3
ndc (package): 70771-1087-6
ndc (package): 70771-1086-6
ndc (package): 70771-1087-5
ndc (package): 70771-1088-1
ndc (package): 70771-1088-6
ndc (package): 70771-1086-9
ndc (package): 70771-1088-4
ndc (package): 70771-1086-3
ndc (package): 70771-1088-5
ndc (package): 70771-1087-9
ndc (package): 70771-1087-2
ndc (package): 70771-1088-9
ndc (package): 70771-1086-5
ndc (package): 70771-1087-1
ndc (package): 70771-1088-2
ndc (package): 70771-1086-2
ndc (package): 70771-1087-4
ndc (package): 70771-1086-4
ndc (product): 70771-1087
ndc (product): 70771-1086
ndc (product): 70771-1088
ndc11 (package): 70771108603
ndc11 (package): 70771108802
ndc11 (package): 70771108604
ndc11 (package): 70771108602
ndc11 (package): 70771108803
ndc11 (package): 70771108606
ndc11 (package): 70771108709
ndc11 (package): 70771108805
ndc11 (package): 70771108801
ndc11 (package): 70771108705
ndc11 (package): 70771108609
ndc11 (package): 70771108601
ndc11 (package): 70771108706
ndc11 (package): 70771108703
ndc11 (package): 70771108702
ndc11 (package): 70771108804
ndc11 (package): 70771108806
ndc11 (package): 70771108704
ndc11 (package): 70771108701
ndc11 (package): 70771108809
ndc11 (package): 70771108605
spl id: e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0
spl set id: f405a774-bd91-4513-b7c7-c44f0596d988

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.