Glimepiride

Product NDC
63187-641
11-digit product format
631870641
Labeler code
63187
Product ID
63187-641_539f397e-9afb-444a-ac5b-c26f4bd791ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
Substance
GLIMEPIRIDE
Active strength
2 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
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
63187-641-30Glimepiride30 in 1 BOTTLETABLET304
63187-641-60Glimepiride60 in 1 BOTTLETABLET604
63187-641-90Glimepiride90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-641GLIMEPIRIDE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221027_beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b4
199246glimepiride 2 MG Oral TabletSCDbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-641-306318706413030 TABLET in 1 BOTTLE (63187-641-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-641-606318706416060 TABLET in 1 BOTTLE (63187-641-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-641-906318706419090 TABLET in 1 BOTTLE (63187-641-90) 90 tablet2018-12-010000-00-00NoNoCurrent