FDA.reportPublic FDA data

NDC 68084-326-11 - Glimepiride

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
68084-326
Requested NDC
68084-326-11
Package NDCs from labels
68084-326-11, 68084-326-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glimepiride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-08HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - American Health PackagingAmerican Health Packaging2024-11-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-326-01Glimepiride100 in 1 BOX, UNIT-DOSETABLET10011
68084-326-11Glimepiride1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-326GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241122_0003458f-352a-46fa-9d99-230daa76ae29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-326-01EA - Each68084-326f61a2576-df26-4973-a414-2d93c5a55c5a12012-07-24
68084-326-11EA - Each68084-326a5a8135f-a711-4fe8-99e4-435519d2a0c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3

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 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199246
unii: 6KY687524K
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
GlimepirideGLIMEPIRIDECardinal Health 107, LLCcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa2026-05-08Warnings, Adverse reactionsExact identifier
application number: ANDA077091
ndc (package): 55154-8175-0
ndc (product): 55154-8175
rxcui: 199246
spl id: 016a7af5-dcca-441d-9a7b-3f7403ed5941
spl set id: cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.f69e36b9-4940-4f01-b5ea-59dc66dc1e872026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.744a5cca-7863-491a-b43a-1b649791702c2026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
GlimepirideGLIMEPIRIDEBryant Ranch Prepack248c3cb3-4501-4b85-bd1d-0624b6afda2c2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEBryant Ranch Prepack90d675cb-6def-49a3-b8b4-229f19d6b6172026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.647a146c-c752-4589-8619-aed5c720ca542026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.ed7a3a8e-97dd-4a5a-9497-001acfd2f1f02026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEAurobindo Pharma Limited28eefc95-d92e-4555-b6c5-2933860b06102026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 1K09F3G675
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
GlimepirideGLIMEPIRIDEBryant Ranch Prepack62780d2e-083d-4bcb-99ff-1b1b4ade60d92026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K

Reported adverse events (FAERS/openFDA)#

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