Glimepiride

Product NDC
53217-323
11-digit product format
532170323
Labeler code
53217
Product ID
53217-323_70915671-efee-4a8a-81a2-3eceb50a2a36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077911
Marketing category
ANDA
Marketing start
2012-01-01
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-323-90Glimepiride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-323GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20180601_5659e616-4858-4543-8e0b-c5477519f8fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN5659e616-4858-4543-8e0b-c5477519f8fe2
199246glimepiride 2 MG Oral TabletSCD5659e616-4858-4543-8e0b-c5477519f8fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-323-905321703239090 in 1 BOTTLEHistorical