Glimepiride

Product NDC
55154-8175
11-digit product format
551548175
Labeler code
55154
Product ID
55154-8175_016a7af5-dcca-441d-9a7b-3f7403ed5941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA077091
Marketing category
ANDA
Marketing start
2009-04-22
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-8175-0Glimepiride1 in 1 BLISTER PACKTABLET18
55154-8175-0Glimepiride10 in 1 BAGTABLET108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8175GLIMEPIRIDE TABLET [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20240331_cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa8
199246glimepiride 2 MG Oral TabletSCDcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8175-05515481750010 BLISTER PACK in 1 BAG (55154-8175-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2009-04-220000-00-00NoNoCurrent