FDA.reportPublic FDA data

NDC 68071-5217-00 - GLYBURIDE

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
68071-5217
Requested NDC
68071-5217-00
Package NDCs from labels
68071-5217-0, 68071-5217-00
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glyburide Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-06-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5217-02022-02-07C16284748780-1d6a99b39-d523-a426-e053-dadaa90af4c2Glyburide Tablets, USP Rx only
68071-5217-02022-01-28C16284748780-1d6a99b39-d523-a426-e053-dadaa90af4c2Glyburide Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5217-0GLYBURIDE100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5217GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240622_a1233548-bbb8-34aa-e053-2a95a90aea53.zip

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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack4dcef36f-000e-43f5-8d67-0e2a079ab2c62026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepackb5ccf5da-cbe1-4009-ba1c-990050838ee92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepacka086cc29-cb5d-40d0-a57d-8e91f1aa91582026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b38213bb-d663-4c95-a1b2-96c23ee5be092026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.372af566-d6ec-446f-88db-0b4cc83b577f2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited7010b662-8b34-49ce-8e5b-73dee0821a602026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GlyburideGLYBURIDEREMEDYREPACK INC.524eec41-37ee-419a-b7a1-d23e888ae6ab2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.2239742b-74e1-4bc2-b5a8-15c4758d6f7b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteddf752bd4-e197-40a4-a01b-d48ba2c105162026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEBryant Ranch Prepack9cdd30e7-512a-4f00-a4de-0a154d143ce92026-05-18Adverse reactionsExact identifier
application number: ANDA090937
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEREMEDYREPACK INC.e23b9a3b-0184-4d1c-8e2c-668697a6da872026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEPreferred Pharmaceuticals Inc.cf21c8c0-7247-4d5b-97f8-ae40161446422026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a58ff524-e975-4d51-a896-e869f8ea66242026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c284c146-436b-4eea-9dca-d7d21c82778c2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsf43c087a-7135-4a79-8463-fe5e9319da912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsd87dade1-55fe-4e77-91b9-b642022a2b8a2026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GlyburideGLYBURIDEPreferred Pharmaceuticals Inc.bc8df889-25e0-49a0-bbec-a3dfae8bbb8a2026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GlyburideGLYBURIDEA-S Medication Solutions51cf08e2-8a2f-4bde-996f-f431f1a68abd2026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.ffd31d06-6011-34e2-e053-6394a90a437f2026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC

Reported adverse events (FAERS/openFDA)#

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