FDA.reportPublic FDA data

Glimepiride

Product NDC
51655-381
11-digit product format
516550381
Labeler code
51655
Product ID
51655-381_4a3efe52-7f76-25a1-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA202112
Marketing category
ANDA
Marketing start
2017-02-24
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-381-522026-01-08C16284748780-19d75b9d0-5599-f424-e053-dadaa90a57ceGlimepiride 2mg
51655-381-522020-01-31C16284748780-19d75b9d0-5599-f424-e053-dadaa90a57ceGlimepiride 2mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-381GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20170309_4a3efe52-7f75-25a1-e054-00144ff8d46c.zip