FDA.reportPublic FDA data

NDC 68788-8508-03 - 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
68788-8508
Requested NDC
68788-8508-03
Package NDCs from labels
68788-8508-3, 68788-8508-6, 68788-8508-9, 68788-8508-1, 68788-8508-03
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLYBURIDE TABLETS, USP For Oral Use 1.25, 2.5, and 5 mgPreferred Pharmaceuticals Inc.2026-05-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8508-1Glyburide100 in 1 BOTTLETABLET1004
68788-8508-3Glyburide30 in 1 BOTTLETABLET304
68788-8508-6Glyburide60 in 1 BOTTLETABLET604
68788-8508-9Glyburide90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8508GLYBURIDE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240517_cf21c8c0-7247-4d5b-97f8-ae4016144642.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8508-1EA - Each68788-85083a4becec-d1e8-4b49-bd8a-3b36fca8663e12023-10-16
68788-8508-3EA - Each68788-850867ba0f47-f380-47c5-9b09-6bbe4087146f12023-10-16
68788-8508-6EA - Each68788-85088e1ababd-cef1-4ab0-bc5c-ff74d1d3ef2012023-10-16
68788-8508-9EA - Each68788-8508fee2326f-881f-492c-9b20-1110e3b0fa7512023-10-16

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 4 · 65 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
application number: ANDA203379
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
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEREMEDYREPACK INC.e23b9a3b-0184-4d1c-8e2c-668697a6da872026-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEPreferred Pharmaceuticals Inc.cf21c8c0-7247-4d5b-97f8-ae40161446422026-05-07Warnings, Adverse reactionsExact identifier
application number: ANDA203379
ndc (package): 68788-8508-9
ndc (package): 68788-8508-3
ndc (package): 68788-8508-1
ndc (package): 68788-8508-6
ndc (product): 68788-8508
ndc11 (package): 68788850803
rxcui: 310537
spl id: a4d8afca-575f-43ba-9a84-30c00a07a015
spl set id: cf21c8c0-7247-4d5b-97f8-ae4016144642
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
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
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

Reported adverse events (FAERS/openFDA)#

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