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 2 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC3f7dc283-b168-8251-e063-6294a90a45a22025-12-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC3f7da2a3-ca46-d3e8-e063-6294a90abef32025-12-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEChartwell RX, LLCe464c8dd-5222-4a6b-b7e9-ca608a403c6e2025-12-22Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEAccord Healthcare, Inc.61496a1e-17bf-4f45-a20c-5bb98fe545ee2025-12-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvKARE94471401-a516-0fe7-ec9c-447dd2bee9722025-12-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEUpsher-Smith Laboratories, LLC3ee6835a-7a7d-49a9-8460-2f1dd270ead32025-12-11Warnings, Adverse reactionsExact identifier
application number: ANDA074625
ndc (package): 0832-0038-89
ndc (package): 0832-0038-01
ndc (package): 0832-0038-00
ndc (package): 0832-0038-10
ndc (package): 0832-0038-50
ndc (product): 0832-0038
ndc11 (package): 00832003889
rxcui: 863664
spl id: 45af3420-b44f-39a1-e063-6394a90ad626
spl set id: 3ee6835a-7a7d-49a9-8460-2f1dd270ead3
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAjanta Pharma USA Inc.95c2a144-ba0d-4011-ae0f-0e0ca876e8a82025-11-30Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions44990ed6-b8e7-40f5-b636-e848024ec6d82025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions0697b3cf-b146-47c0-b5a5-5905ae8d1c972025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEVERITYRX, LLC427b6ffb-3ff4-932f-e063-6394a90ae8b92025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.b5653b7e-1e3b-4da3-b3a2-33318f448c672025-10-20Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.e466d963-469a-4b1c-87f9-2e3e1e9bdf3d2025-10-02Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEMajor Pharmaceuticals7769ad3d-6228-4b2d-8f44-4efe990d3fad2025-09-19Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECardinal Health 107, LLC8455b543-81ce-4522-ae9b-8396f944945c2025-08-18Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.8bd5dce0-d56a-4e64-8de7-e7cd7775526b2025-08-18Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEMajor Pharmaceuticals7688cce8-797d-454c-95fb-52689741582e2025-07-15Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDERising Pharma Holdings, Inc.ab431781-3183-4638-b656-f40a61f079402025-05-19Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAvKARE3418ca19-feb0-9821-e063-6394a90ae8192025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvPAK242b4766-bc2b-0073-d72d-1bf879bbee242025-04-17Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.9c8ced4b-94de-4df8-bea3-b42b8846b7692025-03-12Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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