FDA.reportPublic FDA data

NDC 70518-4035-01 - 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
70518-4035
Requested NDC
70518-4035-01
Package NDCs from labels
70518-4035-0, 70518-4035-1, 70518-4035-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-12
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.2026-06-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4035-0Glyburide30 in 1 BLISTER PACKTABLET303
70518-4035-1Glyburide360 in 1 BOTTLE, PLASTICTABLET3603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4035GLYBURIDE TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20240312_524eec41-37ee-419a-b7a1-d23e888ae6ab.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 2 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyburideGLYBURIDEA-S Medication Solutions51cf08e2-8a2f-4bde-996f-f431f1a68abd2026-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310537
unii: SX6K58TVWC
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.ffd31d06-6011-34e2-e053-6394a90a437f2026-01-16Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310537
unii: SX6K58TVWC
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.486fec17-ff83-3bab-e063-6394a90a5ef02026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENorthwind Health Company, LLCadb751e0-19f6-3f41-e053-2a95a90a2df82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENorthwind Health Company, LLCd9cb9251-7b31-72a0-e053-2a95a90a43152026-01-01Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENorthwind Health Company, LLCdb47a517-f8bb-136f-e053-2a95a90ad8c52026-01-01Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsfaa19e1b-2782-4bf1-a93f-84755f7aa53f2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEChartwell RX, LLC7e661288-2d24-4403-86a1-754afa1d04ff2025-12-09Adverse reactionsExact identifier
rxcui: 310537
rxcui: 197737
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDECoupler LLC4573af7f-3c71-e323-e063-6394a90aa9eb2025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.33418bba-c5ea-4c0f-9d28-31dc2724c6c32025-10-31Adverse reactionsExact identifier
rxcui: 310537
rxcui: 197737
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDEBryant Ranch Prepackdb074991-1267-454a-8b1d-b6f52e2132cc2025-10-03Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310537
unii: SX6K58TVWC
GlyburideGLYBURIDEProficient Rx LP6f65131c-90df-45ab-95fb-c36f411c6fbe2025-07-01Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.d2b109e4-b743-4c5b-98fa-8e1ff4491dd02025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SX6K58TVWC
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.7ee41cd3-461f-3408-e053-2991aa0a863d2025-02-06Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEBryant Ranch Prepack05341afe-5b7a-462a-a196-689cb09f83fc2025-01-28Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
GlyburideGLYBURIDEA-S Medication Solutions676c0e45-0aa2-4060-ad18-67abb9873a502024-10-28Warnings, Adverse reactionsExact identifier
application number: ANDA203379
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.25516c2a-f1b5-9ee4-e063-6394a90ab46b2024-10-25Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC

Reported adverse events (FAERS/openFDA)#

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