FDA.reportPublic FDA data

Glimepiride

Product NDC
68071-2385
11-digit product format
680712385
Labeler code
68071
Product ID
68071-2385_4b312260-7040-713e-e063-6294a90a17f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199246

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2385-62023-01-30C16284748780-1f386c649-b510-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995
68071-2385-82023-01-30C16284748780-1f386c649-b510-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995
68071-2385-92023-01-30C16284748780-1f386c649-b510-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2385-6Glimepiride60 in 1 BOTTLETABLET602
68071-2385-8Glimepiride180 in 1 BOTTLETABLET1802
68071-2385-9Glimepiride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2385GLIMEPIRIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 3 package rows20210410_bf8e5993-5ee7-d26d-e053-2a95a90ae5df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNbf8e5993-5ee7-d26d-e053-2a95a90ae5df2
199246glimepiride 2 MG Oral TabletSCDbf8e5993-5ee7-d26d-e053-2a95a90ae5df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2385-66807123850660 TABLET in 1 BOTTLE (68071-2385-6) 60 tablet2021-04-090000-00-00NoNoCurrent
68071-2385-868071238508180 TABLET in 1 BOTTLE (68071-2385-8) 180 tablet2021-04-090000-00-00NoNoCurrent
68071-2385-96807123850990 TABLET in 1 BOTTLE (68071-2385-9) 90 tablet2021-04-090000-00-00NoNoCurrent