FDA.reportPublic FDA data

NDC 68788-8728-03 - 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
68788-8728
Requested NDC
68788-8728-03
Package NDCs from labels
68788-8728-3, 68788-8728-6, 68788-8728-9, 68788-8728-1, 68788-8728-03
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glimepiride - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2026-05-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8728-1Glimepiride100 in 1 BOTTLETABLET1003
68788-8728-3Glimepiride30 in 1 BOTTLETABLET303
68788-8728-6Glimepiride60 in 1 BOTTLETABLET603
68788-8728-9Glimepiride90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8728GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240820_f69e36b9-4940-4f01-b5ea-59dc66dc1e87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8728-1EA - Each68788-87280d114b83-466b-4c31-aa45-ecf4e64a1b2712024-10-04
68788-8728-3EA - Each68788-87287bc7d0bf-1345-42f5-8948-5f141ffa31b412024-10-04
68788-8728-6EA - Each68788-87280d0c1f07-190f-443b-a1b4-7f9c5398697912024-10-04
68788-8728-9EA - Each68788-8728a5cb6f40-6842-407a-8da7-6c61eff390e412024-10-04

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 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
GlimepirideGLIMEPIRIDESt. Mary's Medical Park Pharmacyfc9d8495-184c-3af1-e053-6394a90a5e292026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDECardinal Health 107, LLCcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa2026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.f69e36b9-4940-4f01-b5ea-59dc66dc1e872026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA202112
ndc (package): 68788-8728-9
ndc (package): 68788-8728-3
ndc (package): 68788-8728-1
ndc (package): 68788-8728-6
ndc (product): 68788-8728
ndc11 (package): 68788872803
rxcui: 199246
spl id: 31dedbcc-cef1-4d2f-adba-0738761d2300
spl set id: f69e36b9-4940-4f01-b5ea-59dc66dc1e87
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.744a5cca-7863-491a-b43a-1b649791702c2026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEBryant Ranch Prepack248c3cb3-4501-4b85-bd1d-0624b6afda2c2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEBryant Ranch Prepack90d675cb-6def-49a3-b8b4-229f19d6b6172026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.647a146c-c752-4589-8619-aed5c720ca542026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.ed7a3a8e-97dd-4a5a-9497-001acfd2f1f02026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEAurobindo Pharma Limited28eefc95-d92e-4555-b6c5-2933860b06102026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEBryant Ranch Prepack62780d2e-083d-4bcb-99ff-1b1b4ade60d92026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1450f455-a14a-4f9b-b3aa-dae49ea0c1862026-02-26Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.bf8e5993-5ee7-d26d-e053-2a95a90ae5df2026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEProficient Rx LPdbed06f9-7758-4c96-9af0-1ed6103db7df2026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEProficient Rx LPe12ab052-e3d6-4246-b727-f1e3f9057f092026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDECoupler LLC41bf4a72-9288-50a1-e063-6394a90a5e7c2026-01-19Warnings, Adverse reactionsExact identifier
application number: ANDA202112
rxcui: 199246
unii: 6KY687524K

Reported adverse events (FAERS/openFDA)#

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