FDA.reportPublic FDA data

NDC 0832-0038-89 - Oxybutynin Chloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0832-0038
Requested NDC
0832-0038-89
Package NDCs from labels
0832-0038-00, 0832-0038-50, 0832-0038-10, 0832-0038-89, 0832-0038-01
Manufacturer
Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc
Effective date
2025-12-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxybutynin Chloride - Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, IncUpsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc2025-12-11HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - RedPharm Drug, Inc.RedPharm Drug, Inc.2022-01-20HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride Tablets, USPREMEDYREPACK INC.2019-12-18HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride Tablets, USPREMEDYREPACK INC.2019-08-14HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Aidarex Pharmaceuticals LLC | Aidarex PharmaceuticalsAidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals2018-08-13HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - A-S Medication SolutionsA-S Medication Solutions2017-09-21HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2016-06-15HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2013-09-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0038-00Oxybutynin Chloride100 in 1 BOTTLETABLET10017
0832-0038-01Oxybutynin Chloride100 in 1 CARTONTABLET10017
0832-0038-10Oxybutynin Chloride1000 in 1 BOTTLETABLET100017
0832-0038-50Oxybutynin Chloride500 in 1 BOTTLETABLET50017
0832-0038-89Oxybutynin Chloride1 in 1 BLISTER PACKTABLET117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0038OXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]15Current NDC, Legacy NDC, 5 package rows20230921_3ee6835a-7a7d-49a9-8460-2f1dd270ead3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0038-00EA - Each0832-0038f3763031-4e45-4646-a8ba-3d7de1546c3512012-07-24
0832-0038-01EA - Each0832-00381d2f3647-37a1-426a-948e-97432f95886d12018-06-11
0832-0038-10EA - Each0832-0038177cafb0-d308-4e31-89b9-4595cb6ea70e12012-07-24
0832-0038-50EA - Each0832-003845fb36e1-d85b-47fb-970b-be7fd4528abb12012-07-24
0832-0038-89EA - Each0832-0038ebc21517-3bb5-4b5e-a6ad-415af411acff12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxybutynin ChlorideACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
OxybutyninACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
calcium stearateINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

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 4 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions7593becc-250f-4d25-8401-a9f72f3f5ad42024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions8f147f73-cfc6-40a3-b1a3-e4cab18685232024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions39a2d144-0c10-4aec-9fa4-0adc24b332eb2024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack169d6d58-8887-4bdd-95bd-873d1f049eaa2024-05-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEProficient Rx LP7d2332b4-9e48-4bb2-a2c3-75e16e1d455b2024-04-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack2f898b29-46cf-4427-bb64-8c30532222f52024-01-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions5e3b454b-6d3c-418b-8ac2-b0e17f018bbf2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutionsafc6a3aa-e43d-4f10-bdbd-570a149bf9db2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINZydus Pharmaceuticals USA Inc.c042bf06-79a3-4dc7-ae05-3ef3cfae9d442023-11-07Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions83522acd-0ecc-46ac-a018-a3205ba096ff2023-11-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5b72d34e-ae57-4459-ba2c-3bae8a69c5c12023-10-04Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2023-05-31Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2bb6927-5fbf-49ca-a891-d701bff1c8122023-05-31Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDELannett Company, Inc.c5950dba-d92b-46a0-993f-af9f9ddb52bf2023-05-30Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINA-S Medication Solutions1f95920c-5dc2-44e4-b61d-b2c5e05390ba2023-02-06Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmneal Pharmaceuticals LLC53924eba-1919-4203-9a1e-d57dfdd3b9632023-02-02Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC1e1c1043-e4c5-4a06-9cc1-45d4397746f42023-01-04Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEProficient Rx LPe3f0c249-8085-4979-823a-820e233a284f2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEProficient Rx LP88f08450-559e-4038-aad1-051e4ab283cf2022-06-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDELeading Pharma, LLCb73b8338-8045-448f-87a6-3d289227d00e2022-02-14Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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