FDA.reportPublic FDA data

NDC 70518-3504-01 - 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
70518-3504
Requested NDC
70518-3504-01
Package NDCs from labels
70518-3504-0, 70518-3504-1, 70518-3504-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-05-15
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 mgREMEDYREPACK INC.2026-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3504-0Glyburide30 in 1 BLISTER PACKTABLET308
70518-3504-1Glyburide30 in 1 BLISTER PACKTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3504GLYBURIDE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240213_e23b9a3b-0184-4d1c-8e2c-668697a6da87.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 3 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.21786ac0-da3c-16cb-e063-6394a90a45962024-09-06Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.3e354b4d-70e4-5089-e054-00144ff88e882024-08-13Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a12342fb-123c-2951-e053-2a95a90ac5962024-06-20Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a1233548-bbb8-34aa-e053-2a95a90aea532024-06-20Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.901c50d5-31e7-b073-e053-2995a90abfeb2024-06-19Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.7facb5ac-c1d5-43b4-e053-2991aa0a2a7b2024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack8f2951ab-20c3-4216-b250-4c6a62d322032024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
GlyburideGLYBURIDEA-S Medication Solutionsd090f978-b1a5-4db7-951d-3f32dd06966c2024-01-02Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEA-S Medication Solutions7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd2023-12-03Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEA-S Medication Solutions922d1080-52c6-41e4-a310-533d8ca185942023-08-28Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEA-S Medication Solutions3c91a408-973b-4572-832f-515f61d5be1f2023-02-04Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GlyburideGLYBURIDETeva Pharmaceuticals USA, Inc.e84c0dfc-a4e9-4c89-b6ea-45732eb412f52023-01-09Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GlyburideGLYBURIDECadila Pharmaceuticals Limitedea7a055b-64f0-46bf-aa8e-4a2ef5c3c0352022-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310537
rxcui: 197737
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEModavar Pharmaceuticals LLCa5de0ef6-4c8b-40ab-b0ed-2003a80867502022-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA203379
ndc (product): 72241-039
rxcui: 310537
rxcui: 197737
rxcui: 310534
spl id: 7ebf5b06-fdd3-4120-93f2-d31def5bf104
spl set id: a5de0ef6-4c8b-40ab-b0ed-2003a8086750
unii: SX6K58TVWC
glyburideGLYBURIDEZydus Lifesciences Limited5d0e406f-285d-4716-8971-82f6653455172022-11-16Adverse reactionsExact identifier
rxcui: 310537
rxcui: 197737
rxcui: 310534
unii: SX6K58TVWC
glyburideGLYBURIDEZydus Pharmaceuticals (USA) Inc.87781ea8-62ec-483c-a4dd-8c965ce594852022-11-16Adverse reactionsExact identifier
rxcui: 310537
rxcui: 197737
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDETEVA Pharmaceuticals USA Inc50d16f1d-c814-4411-8749-62561321ecce2021-07-01Warnings, Adverse reactionsExact identifier
rxcui: 310537
rxcui: 197737
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEProficient Rx LPec45f0d8-cab8-4822-895b-17bb443a4f982019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEProficient Rx LPb292cb9b-7348-4c07-a871-bc091229fdf82019-11-01Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC

Reported adverse events (FAERS/openFDA)#

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