FDA.reportPublic FDA data

NDC 68788-8141-09 - 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
68788-8141
Requested NDC
68788-8141-09
Package NDCs from labels
68788-8141-9, 68788-8141-09
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OXYBUTYNIN CHLORIDE TABLETS, USP Rx onlyPreferred Pharmaceuticals Inc.2026-01-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8141-9Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8141OXYBUTYNIN CHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20240727_0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8141-9EA - Each68788-8141cc53d5aa-79b2-49ae-bd79-f4c5c11a0a0f12022-03-09

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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEREMEDYREPACK INC.1a08a16a-f16d-4ef1-95bb-6943bcae07372026-07-28Warnings, Adverse reactionsExact identifier
application number: ANDA209335
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDETruPharma LLC7c497c6c-2448-2c80-e053-2991aa0ab8c72026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERISING PHARMA HOLDINGS, INC.9578b6b8-5b9d-4263-9142-39b2c7216b852026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEATLANTIC BIOLOGICALS CORP.fe4ed76b-0009-455f-be30-47e80fc1afdf2026-07-09Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC55f618d1-4463-3200-e063-6394a90a89a82026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limited9ede5def-d185-4e40-9c10-8663ac654caf2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAmerican Health Packaging0c71bdfb-01db-49ac-a8e9-0037df0d24af2026-06-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limitedac10c7b7-d0cb-4068-93e2-c0e51f15866e2026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.73d715dc-868d-4194-b668-4c39ababa6982026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepacka5965c8b-179d-4665-8a3b-324b693607ee2026-05-19Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepack7db4ab81-b379-4a6d-b469-95eb9e184b562026-05-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmerican Health Packaging4574b227-9726-4798-bac2-83bfb9616f092026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutionsb9d0e5c8-3a71-40a0-a7d3-44bc043392fa2026-02-17Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae12026-02-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9a551ec5-7e80-47c9-a7b9-f458c14781742026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEChartwell Governmental & Specialty RX, LLC.46e78c72-a5a3-472f-9125-b120fa4eee312026-01-30Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPreferred Pharmaceuticals Inc.0e002fe8-fa3f-4a7d-84df-0c6e031e6ae42026-01-15Warnings, Adverse reactionsExact identifier
application number: ANDA209335
ndc (package): 68788-8141-9
ndc (product): 68788-8141
ndc11 (package): 68788814109
rxcui: 863664
spl id: c96411f4-50fe-42a7-9463-5bb9d2939ac3
spl set id: 0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAdvagen Pharma Limited7bd31561-4c76-4c6b-819b-4925498866732026-01-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutions3688227b-7655-40ca-b34b-073a39fd60f42026-01-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLCf330b7a0-bbe0-0f00-e053-2a95a90a37b82026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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