oxybutynin

Product NDC
70771-1087
11-digit product format
707711087
Labeler code
70771
Product ID
70771-1087_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
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

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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 70771-1087
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
oxybutyninOXYBUTYNINA-S Medication Solutions1f95920c-5dc2-44e4-b61d-b2c5e05390ba2023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202332
application number: ANDA202332

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 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
f405a774-bd91-4513-b7c7-c44f0596d988Available 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
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1087OXYBUTYNIN 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
70771-1087-170771108701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1087-1) 2017-08-100000-00-00NoNoCurrent
70771-1087-27077110870210 in 1 BLISTER PACKHistorical
70771-1087-37077110870330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1087-3) 2017-08-100000-00-00NoNoCurrent
70771-1087-47077110870410 BLISTER PACK in 1 CARTON (70771-1087-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1087-2) 10 blister pack2017-08-100000-00-00NoNoCurrent
70771-1087-570771108705500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1087-5) 2017-08-100000-00-00NoNoCurrent
70771-1087-67077110870660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1087-6) 2017-08-100000-00-00NoNoCurrent
70771-1087-97077110870990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1087-9) 2017-08-100000-00-00NoNoCurrent