FDA.reportPublic FDA data

NDC 50090-6322-01 - Glimepiride

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
50090-6322
Requested NDC
50090-6322-01
Package NDCs from labels
50090-6322-1, 50090-6322-4, 50090-6322-2, 50090-6322-3, 50090-6322-0, 50090-6322-01
Manufacturer
A-S Medication Solutions
Effective date
2023-09-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glimepiride - A-S Medication SolutionsA-S Medication Solutions2023-09-06Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6322-0Glimepiride30 in 1 BOTTLETABLET303
50090-6322-1Glimepiride100 in 1 BOTTLETABLET1003
50090-6322-2Glimepiride60 in 1 BOTTLETABLET603
50090-6322-3Glimepiride90 in 1 BOTTLETABLET903
50090-6322-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6322GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 5 package rows20230907_a11680ba-2750-43ab-a1b1-a52ebe3e139f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6322-0EA - Each50090-6322d8776c79-017f-4a41-a2ee-f77cb15fb1b812023-02-06
50090-6322-1EA - Each50090-632225485073-8362-4bda-953e-f01955ea6ea612023-02-06
50090-6322-2EA - Each50090-63227959c83d-25d7-473d-ad9c-0a4b56b04c5312023-02-06
50090-6322-3EA - Each50090-63228176d336-f527-43a5-ada5-8db5c386b9c912023-02-06
50090-6322-4EA - Each50090-632214490013-f258-4fff-98a7-85dc565bb7aa12023-02-06

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 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEA-S Medication Solutions0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b2023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutionsa9461830-1c4f-4bc4-b622-1c44112a76b92023-12-03Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutionsa11680ba-2750-43ab-a1b1-a52ebe3e139f2023-09-06Warnings, Adverse reactionsExact identifier
application number: ANDA202759
ndc (package): 50090-6322-4
ndc (package): 50090-6322-1
ndc (package): 50090-6322-3
ndc (package): 50090-6322-2
ndc (package): 50090-6322-0
ndc (product): 50090-6322
ndc11 (package): 50090632201
rxcui: 199247
spl id: f6d891ed-a372-4f20-b4d3-a77f3af53d71
spl set id: a11680ba-2750-43ab-a1b1-a52ebe3e139f
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutionse8da2484-43a7-4dcb-84d5-d84596feb9f62023-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA202759
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutionsdef20e38-01f7-4ead-beb6-3dc11062a3422023-06-22Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEProficient Rx LP8f687fa6-54eb-4556-8ea6-aafec49a87d12023-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA202759
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDESolco Healthcare U.S., LLC86acdd9e-8637-43e4-8bf7-b3a123b871b82021-08-13Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEBryant Ranch Prepackebb9f080-b11d-5d18-36f0-627107e7fbcd2020-08-27Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDENCS HealthCare of KY, Inc dba Vangard Labs669a67c2-2f97-4b7e-8bba-83a015e0fa942020-04-30Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEAphena Pharma Solutions - Tennessee, LLC00b9e312-921e-41e6-ad27-0a6ce87f82982019-02-13Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEDr. Reddy's Laboratories Limited07ad4366-4b21-f633-49f3-c2b35f88168d2019-01-16Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K

Reported adverse events (FAERS/openFDA)#

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