Glimepiride

Product NDC
82804-140
11-digit product format
828040140
Labeler code
82804
Product ID
82804-140_1f102e4c-1954-4f17-8c60-4dad79f25a25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Substance
GLIMEPIRIDE
Active strength
1 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
82804-140-308280401403030 TABLET in 1 BOTTLE (82804-140-30) 30 tablet2024-09-11NoNoHistorical
82804-140-908280401409090 TABLET in 1 BOTTLE (82804-140-90) 90 tablet2024-09-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GlimepirideProficient Rx LP2024-09-01HUMAN PRESCRIPTION DRUG LABEL1