oxybutynin

Product NDC
50090-5352
Requested package NDC
50090-5352-0
11-digit product format
500905352
Labeler code
50090
Product ID
50090-5352_890289a8-7be5-4750-b2a3-8b20c11650f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202332
Marketing category
ANDA
Marketing start
2017-08-10
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-535250090-5352-0IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5352-0oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5352OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210615_4ef97dd9-77a1-49a3-896b-ea810efbbd53.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
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 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5352-05009053520090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5352-0) 2020-11-110000-00-00NoNoCurrent