Glimepiride

Product NDC
42571-100
11-digit product format
425710100
Labeler code
42571
Product ID
42571-100_34e9a6b6-450b-7d20-e063-6294a90ac831
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA091220
Marketing category
ANDA
Marketing start
2013-06-13
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui153842, 199245, 199246, 199247, 1361493, 1361495

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-100-01Glimepiride100 in 1 BOTTLETABLET10091233
42571-100-05Glimepiride500 in 1 BOTTLETABLET50091233

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-100-01EA - Each42571-100ea561710-c049-44bc-bb09-bf5d3c9b7e2512013-04-01
42571-100-05EA - Each42571-10054369bac-a4d8-46d2-8b9c-22de7a016a9612013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [MICRO LABS LIMITED]91224

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-100GLIMEPIRIDE (GLIMEPIRIDE) TABLET [MICRO LABS LIMITED]91233Current NDC, Legacy NDC, 2 package rows20250513_60e9397e-83b9-489e-9683-6f87e458bbaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
199246glimepiride 2 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
153842glimepiride 3 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
199247glimepiride 4 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361493glimepiride 6 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361495glimepiride 8 MG Oral TabletPSN60e9397e-83b9-489e-9683-6f87e458bbaa91233
199245glimepiride 1 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
199246glimepiride 2 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
153842glimepiride 3 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
199247glimepiride 4 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361493glimepiride 6 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
1361495glimepiride 8 MG Oral TabletSCD60e9397e-83b9-489e-9683-6f87e458bbaa91233
199245glimepiride 1 MG Oral TabletPSNd4513181-4558-4d9a-851b-acf7e3eda25a104
199245glimepiride 1 MG Oral TabletSCDd4513181-4558-4d9a-851b-acf7e3eda25a104
199245glimepiride 1 MG Oral TabletPSN669a67c2-2f97-4b7e-8bba-83a015e0fa941
199246glimepiride 2 MG Oral TabletPSN669a67c2-2f97-4b7e-8bba-83a015e0fa941
199247glimepiride 4 MG Oral TabletPSN669a67c2-2f97-4b7e-8bba-83a015e0fa941
199245glimepiride 1 MG Oral TabletSCD669a67c2-2f97-4b7e-8bba-83a015e0fa941
199246glimepiride 2 MG Oral TabletSCD669a67c2-2f97-4b7e-8bba-83a015e0fa941
199247glimepiride 4 MG Oral TabletSCD669a67c2-2f97-4b7e-8bba-83a015e0fa941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-100-0142571010001100 TABLET in 1 BOTTLE (42571-100-01) 100 tablet2013-06-130000-00-00NoNoCurrent
42571-100-0542571010005500 TABLET in 1 BOTTLE (42571-100-05) 500 tablet2013-06-130000-00-00NoNoCurrent