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 4 of 5 · 86 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
application number: ANDA209335
ndc (package): 50090-4622-1
ndc (package): 50090-4622-3
ndc (package): 50090-4622-0
ndc (product): 50090-4622
ndc11 (package): 50090462201
rxcui: 863664
spl id: b50d393a-fbbf-4184-95a8-aadb8b0468f2
spl set id: 39a2d144-0c10-4aec-9fa4-0adc24b332eb
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
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
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

Reported adverse events (FAERS/openFDA)#

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