Glimepiride

Product NDC
0440-6566
11-digit product format
004406566
Labeler code
0440
Product ID
0440-6566_e54a10e9-29e4-4386-9eba-a05559c96bcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA077911
Marketing category
ANDA
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-6566-01Glimepiride100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-6566GLIMEPIRIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20160805_57d6c173-0ef2-44a1-962e-4df021481c79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN57d6c173-0ef2-44a1-962e-4df021481c792
199247glimepiride 4 MG Oral TabletSCD57d6c173-0ef2-44a1-962e-4df021481c792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-6566-0100440656601100 in 1 BOTTLEHistorical