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#

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 5 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d60ff571-d1c7-0675-e053-2995a90a15aa4eb9441b-27ba-1b8f-e054-00144ff88e882022-01-20Warnings, Adverse reactionsExact identifier
spl id: d60ff571-d1c7-0675-e053-2995a90a15aa
spl set id: 4eb9441b-27ba-1b8f-e054-00144ff88e88
a57495d8-20e9-36bb-e053-2a95a90a09e175055e88-0c36-4593-88ad-4779ebabb3352020-05-12Warnings, Adverse reactionsExact identifier
spl set id: 75055e88-0c36-4593-88ad-4779ebabb335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDELannett Company, Inc.615f3d95-197c-4fec-b81f-c26449c93c3b2020-02-21Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
99f48658-b9cb-253e-e053-2a95a90a20d4c1593399-268b-4266-bc1d-e6d3d61e692f2019-12-18Warnings, Adverse reactionsExact identifier
spl id: 99f48658-b9cb-253e-e053-2a95a90a20d4
spl set id: c1593399-268b-4266-bc1d-e6d3d61e692f
9236c367-4765-43a0-a24e-284ea2d9f000c687e86b-1dc2-4f9c-a032-30f626f54d902018-08-13Warnings, Adverse reactionsExact identifier
spl id: 9236c367-4765-43a0-a24e-284ea2d9f000
spl set id: c687e86b-1dc2-4f9c-a032-30f626f54d90
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
668cabca-35a6-4b47-b356-c6b077a8c0b4f763d619-3b28-4ef7-a41f-d85d8b65cb2e2017-09-21Warnings, Adverse reactionsExact identifier
spl id: 668cabca-35a6-4b47-b356-c6b077a8c0b4
spl set id: f763d619-3b28-4ef7-a41f-d85d8b65cb2e
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC58136f28-70c1-4cf2-bcd7-858c5609431a2016-06-15Warnings, Adverse reactionsExact identifier
application number: ANDA074625
ndc (package): 43353-978-92
ndc (product): 43353-978
rxcui: 863664
spl id: c8f0373d-45aa-49dc-8436-4fc1a9304a57
spl set id: 58136f28-70c1-4cf2-bcd7-858c5609431a
unii: L9F3D9RENQ
7e123e63-4a3a-4a7a-8b45-e3d5ef102106841eea91-2112-4940-868d-25ef085e8c762013-09-26Warnings, Adverse reactionsExact identifier
spl id: 7e123e63-4a3a-4a7a-8b45-e3d5ef102106
spl set id: 841eea91-2112-4940-868d-25ef085e8c76

Reported adverse events (FAERS/openFDA)#

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