Glimepiride

Product NDC
71335-2367
11-digit product format
713352367
Labeler code
71335
Product ID
71335-2367_f95e9e3a-73c3-4a11-a0ec-be1281cdcdd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202112
Marketing category
ANDA
Marketing start
2023-07-31
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6KY687524KGLIMEPIRIDE93479-97-1GLIMEPIRIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2367-17133523670130 TABLET in 1 BOTTLE (71335-2367-1) 30 tablet2024-04-30NoNoHistorical
71335-2367-27133523670260 TABLET in 1 BOTTLE (71335-2367-2) 60 tablet2024-04-30NoNoHistorical
71335-2367-37133523670390 TABLET in 1 BOTTLE (71335-2367-3) 90 tablet2024-04-30NoNoHistorical
71335-2367-471335236704100 TABLET in 1 BOTTLE (71335-2367-4) 100 tablet2024-04-30NoNoHistorical
71335-2367-571335236705180 TABLET in 1 BOTTLE (71335-2367-5) 180 tablet2024-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GlimepirideBryant Ranch Prepack2024-04-30HUMAN PRESCRIPTION DRUG LABEL100