FDA.reportPublic FDA data

Glimepiride

Product NDC
51655-120
11-digit product format
516550120
Labeler code
51655
Product ID
51655-120_4af3a2b4-2da9-f313-e063-6294a90a91bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078181
Marketing category
ANDA
Marketing start
2014-12-29
Substance
GLIMEPIRIDE
Active strength
4 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
GLIMEPIRIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199247

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
51655-120-522023-03-15C16284748780-19d75b9d0-b19a-f424-e053-dadaa90a57ceThese 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
51655-120-522023-01-30C16284748780-19d75b9d0-b19a-f424-e053-dadaa90a57ceThese 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
51655-120-522020-07-06C16284748780-19d75b9d0-b19a-f424-e053-dadaa90a57ceThese 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
51655-120-522020-01-31C16284748780-19d75b9d0-b19a-f424-e053-dadaa90a57ceThese 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
51655-120-26Glimepiride90 in 1 BOTTLE, PLASTICTABLET905
51655-120-52Glimepiride30 in 1 BOTTLE, DISPENSINGTABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-120-52EA - Each51655-120cf626505-3142-4d68-aee5-fe3e993d408612021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-120GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20230316_3e81a39a-30bb-4d6d-82e1-17d7134365be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN3e81a39a-30bb-4d6d-82e1-17d7134365be5
199247glimepiride 4 MG Oral TabletSCD3e81a39a-30bb-4d6d-82e1-17d7134365be5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-120-265165501202690 TABLET in 1 BOTTLE, PLASTIC (51655-120-26) 90 tablet2022-12-06NoNoHistorical
51655-120-525165501205230 TABLET in 1 BOTTLE, DISPENSING (51655-120-52) 30 tablet2014-12-290000-00-00NoNoCurrent