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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA090937
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENorthwind Health Company, LLCdb47a517-f8bb-136f-e053-2a95a90ad8c52026-01-01Adverse reactionsExact identifier
application number: ANDA090937
rxcui: 310534
unii: SX6K58TVWC
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
application number: ANDA090937
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
application number: ANDA090937
ndc (product): 23155-057
rxcui: 310537
rxcui: 197737
rxcui: 310534
spl id: 98ed9f46-1633-4f82-bd51-ff87b0157871
spl set id: 33418bba-c5ea-4c0f-9d28-31dc2724c6c3
unii: SX6K58TVWC
GlyburideGLYBURIDEBryant Ranch Prepackdb074991-1267-454a-8b1d-b6f52e2132cc2025-10-03Warnings, Adverse reactionsExact identifier
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
application number: ANDA090937
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDEBryant Ranch Prepack05341afe-5b7a-462a-a196-689cb09f83fc2025-01-28Adverse reactionsExact identifier
application number: ANDA090937
rxcui: 310537
unii: SX6K58TVWC
GlyburideGLYBURIDEA-S Medication Solutions676c0e45-0aa2-4060-ad18-67abb9873a502024-10-28Warnings, Adverse reactionsExact identifier
rxcui: 310534
unii: SX6K58TVWC
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.25516c2a-f1b5-9ee4-e063-6394a90ab46b2024-10-25Warnings, Adverse reactionsExact identifier
rxcui: 310537
unii: SX6K58TVWC
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
application number: ANDA090937
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a12342fb-123c-2951-e053-2a95a90ac5962024-06-20Adverse reactionsExact identifier
application number: ANDA090937
rxcui: 310537
unii: SX6K58TVWC
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a1233548-bbb8-34aa-e053-2a95a90aea532024-06-20Adverse reactionsExact identifier
application number: ANDA090937
ndc (package): 68071-5217-0
ndc (product): 68071-5217
ndc11 (package): 68071521700
rxcui: 310534
spl id: 1b58e185-0bf6-c0eb-e063-6294a90a4d9f
spl set id: a1233548-bbb8-34aa-e053-2a95a90aea53
unii: SX6K58TVWC

Reported adverse events (FAERS/openFDA)#

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