FDA.reportPublic FDA data

NDC 50090-4622-01 - 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
50090-4622
Requested NDC
50090-4622-01
Package NDCs from labels
50090-4622-0, 50090-4622-1, 50090-4622-3, 50090-4622-01
Manufacturer
A-S Medication Solutions
Effective date
2024-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxybutynin Chloride - A-S Medication SolutionsA-S Medication Solutions2024-06-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4622-02023-02-06OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-12023-02-06OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-32023-02-06OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-02023-01-30OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-12023-01-30OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
50090-4622-32023-01-30OXYBUTYNIN CHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4622-0Oxybutynin Chloride30 in 1 BOTTLETABLET3011
50090-4622-1Oxybutynin Chloride100 in 1 BOTTLETABLET10011
50090-4622-3Oxybutynin Chloride90 in 1 BOTTLETABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4622OXYBUTYNIN CHLORIDE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20240604_39a2d144-0c10-4aec-9fa4-0adc24b332eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4622-0EA - Each50090-4622341581ec-a389-4c39-8913-c2b1c57eb2e712022-12-07
50090-4622-1EA - Each50090-462279095bee-3fb1-4c38-be46-3f6c2720332e12022-12-07
50090-4622-3EA - Each50090-4622f9e87985-b8f4-4b6d-9ca1-73269e326b7312022-12-07

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 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Oxybutynin ChlorideOXYBUTYNIN CHLORIDELannett Company, Inc.615f3d95-197c-4fec-b81f-c26449c93c3b2020-02-21Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC58136f28-70c1-4cf2-bcd7-858c5609431a2016-06-15Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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