Glimepiride

Product NDC
61442-117
11-digit product format
614420117
Labeler code
61442
Product ID
61442-117_2386d706-9dab-4ae0-e063-6394a90a8a06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA077911
Marketing category
ANDA
Marketing start
2012-01-01
Substance
GLIMEPIRIDE
Active strength
4 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
GLIMEPIRIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199245, 199246, 199247

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
61442-117-01Glimepiride100 in 1 BOTTLETABLET10011
61442-117-05Glimepiride500 in 1 BOTTLETABLET50011
61442-117-10Glimepiride1000 in 1 BOTTLETABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-117GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]11Current NDC, Legacy NDC, 3 package rows20241004_72d88c6d-2f0a-4bf8-aa7f-1e1811794187.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN647a146c-c752-4589-8619-aed5c720ca5421
199247glimepiride 4 MG Oral TabletSCD647a146c-c752-4589-8619-aed5c720ca5421
199247glimepiride 4 MG Oral TabletPSNf4ffb19e-6d65-49fd-83ce-514d38d9d97c15
199247glimepiride 4 MG Oral TabletSCDf4ffb19e-6d65-49fd-83ce-514d38d9d97c15
199245glimepiride 1 MG Oral TabletPSN72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199246glimepiride 2 MG Oral TabletPSN72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199247glimepiride 4 MG Oral TabletPSN72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199245glimepiride 1 MG Oral TabletSCD72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199246glimepiride 2 MG Oral TabletSCD72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199247glimepiride 4 MG Oral TabletSCD72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199245glimepiride 1 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199245glimepiride 1 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletPSN57d6c173-0ef2-44a1-962e-4df021481c792
199247glimepiride 4 MG Oral TabletPSN2e1b91a1-f808-4c57-9ef9-743ee48055822
199247glimepiride 4 MG Oral TabletSCD57d6c173-0ef2-44a1-962e-4df021481c792
199247glimepiride 4 MG Oral TabletSCD2e1b91a1-f808-4c57-9ef9-743ee48055822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61442-117-0161442011701100 TABLET in 1 BOTTLE (61442-117-01) 100 tablet2012-01-010000-00-00NoNoCurrent
61442-117-0561442011705500 TABLET in 1 BOTTLE (61442-117-05) 500 tablet2012-01-010000-00-00NoNoCurrent
61442-117-10614420117101000 TABLET in 1 BOTTLE (61442-117-10) 1000 tablet2012-01-010000-00-00NoNoCurrent