FDA.reportPublic FDA data

GLIMEPIRIDE

Product NDC
51655-103
11-digit product format
516550103
Labeler code
51655
Product ID
51655-103_152b12c4-f153-47d0-af0c-51255a7adc77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA077911
Marketing category
ANDA
Marketing start
2015-02-04
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-103-522026-01-07C16284748780-19d75b9d1-09d5-f424-e053-dadaa90a57ceb23d7723-4eef-4dda-9e10-8ccc357a6e89
51655-103-522020-01-31C16284748780-19d75b9d1-09d5-f424-e053-dadaa90a57ceb23d7723-4eef-4dda-9e10-8ccc357a6e89

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-103GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20150325_b23d7723-4eef-4dda-9e10-8ccc357a6e89.zip