GLIMEPIRIDE

Product NDC
54458-967
11-digit product format
544580967
Labeler code
54458
Product ID
54458-967_061c5497-cc54-4874-b5db-81d99d9cfb71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA077091
Marketing category
ANDA
Marketing start
2009-02-06
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
2020-12-31
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
54458-967-10GLIMEPIRIDE30 in 1 BLISTER PACKTABLET3041
54458-967-16GLIMEPIRIDE30 in 1 BOTTLETABLET3041

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-967GLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, LLC]41Legacy NDC, 2 package rows20190227_1873bce1-172f-4eb0-b5bc-cb7d444a8d8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN1873bce1-172f-4eb0-b5bc-cb7d444a8d8e41
199246glimepiride 2 MG Oral TabletPSN1873bce1-172f-4eb0-b5bc-cb7d444a8d8e41
199247glimepiride 4 MG Oral TabletPSN1873bce1-172f-4eb0-b5bc-cb7d444a8d8e41
199245glimepiride 1 MG Oral TabletSCD1873bce1-172f-4eb0-b5bc-cb7d444a8d8e41
199246glimepiride 2 MG Oral TabletSCD1873bce1-172f-4eb0-b5bc-cb7d444a8d8e41
199247glimepiride 4 MG Oral TabletSCD1873bce1-172f-4eb0-b5bc-cb7d444a8d8e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54458-967-105445809671030 TABLET in 1 BLISTER PACK (54458-967-10) 30 tablet2009-02-060000-00-00NoNoCurrent
54458-967-165445809671630 TABLET in 1 BOTTLE (54458-967-16) 30 tablet2017-08-020000-00-00NoNoCurrent