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 1 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
GlimepirideGLIMEPIRIDESt. Mary's Medical Park Pharmacyfc9d8495-184c-3af1-e053-6394a90a5e292026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-06-03WarningsExact identifier
unii: FZ989GH94E
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