Glimepiride

Product NDC
55700-594
11-digit product format
557000594
Labeler code
55700
Product ID
55700-594_2d412182-728c-4822-bafc-e48b8211247a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078181
Marketing category
ANDA
Marketing start
2018-03-23
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-594-902025-01-09C16284748780-1f386c649-b7b6-0266-e053-dadaa90a7c1ac1db49c1-777a-4126-9526-d2e8ef428f52
55700-594-902023-01-30C16284748780-1f386c649-b7b6-0266-e053-dadaa90a7c1ac1db49c1-777a-4126-9526-d2e8ef428f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-594-905570005949090 TABLET in 1 BOTTLE (55700-594-90) 90 tablet2021-05-070000-00-00NoNoCurrent