Glimepiride

Product NDC
63187-698
11-digit product format
631870698
Labeler code
63187
Product ID
63187-698_b1330ae8-15e5-4aca-a5fe-6fb906740eeb
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
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
63187-698-306318706983030 TABLET in 1 BOTTLE (63187-698-30) 30 tablet2016-05-02NoNoHistorical
63187-698-606318706986060 TABLET in 1 BOTTLE (63187-698-60) 60 tablet2016-05-02NoNoHistorical
63187-698-906318706989090 TABLET in 1 BOTTLE (63187-698-90) 90 tablet2016-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GlimepirideProficient Rx LP2022-10-01HUMAN PRESCRIPTION DRUG LABEL5