Glimepiride

Product NDC
71335-1886
11-digit product format
713351886
Labeler code
71335
Product ID
71335-1886_6cd6038e-4934-47ee-8590-66e556eefdcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091220
Marketing category
ANDA
Marketing start
2013-06-13
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
71335-1886-1Glimepiride30 in 1 BOTTLETABLET30102
71335-1886-2Glimepiride60 in 1 BOTTLETABLET60102
71335-1886-3Glimepiride90 in 1 BOTTLETABLET90102
71335-1886-4Glimepiride100 in 1 BOTTLETABLET100102
71335-1886-5Glimepiride180 in 1 BOTTLETABLET180102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN62780d2e-083d-4bcb-99ff-1b1b4ade60d9102
199246glimepiride 2 MG Oral TabletSCD62780d2e-083d-4bcb-99ff-1b1b4ade60d9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1886-17133518860130 TABLET in 1 BOTTLE (71335-1886-1) 30 tablet2021-12-210000-00-00NoNoCurrent
71335-1886-27133518860260 TABLET in 1 BOTTLE (71335-1886-2) 60 tablet2021-12-210000-00-00NoNoCurrent
71335-1886-37133518860390 TABLET in 1 BOTTLE (71335-1886-3) 90 tablet2021-12-210000-00-00NoNoCurrent
71335-1886-471335188604100 TABLET in 1 BOTTLE (71335-1886-4) 100 tablet2021-12-210000-00-00NoNoCurrent
71335-1886-571335188605180 TABLET in 1 BOTTLE (71335-1886-5) 180 tablet2021-12-210000-00-00NoNoCurrent