Glimepiride

Product NDC
63629-5650
11-digit product format
636295650
Labeler code
63629
Product ID
63629-5650_bf2f2303-19c6-4a93-b9ca-6efc1b445124
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-5650-12025-01-30C16284748780-12cef2736-6c54-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral us Initial U.S. Approval: 1995
63629-5650-22025-01-30C16284748780-12cef2736-6c54-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral us Initial U.S. Approval: 1995
63629-5650-32025-01-30C16284748780-12cef2736-6c54-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral us Initial U.S. Approval: 1995
63629-5650-42025-01-30C16284748780-12cef2736-6c54-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral us Initial U.S. Approval: 1995
63629-5650-52025-01-30C16284748780-12cef2736-6c54-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral us Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5650-1Glimepiride30 in 1 BOTTLETABLET301016
63629-5650-2Glimepiride60 in 1 BOTTLETABLET601016
63629-5650-3Glimepiride90 in 1 BOTTLETABLET901016
63629-5650-4Glimepiride100 in 1 BOTTLETABLET1001016
63629-5650-5Glimepiride20 in 1 BOTTLETABLET201016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5650GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]1016Legacy NDC, 5 package rows20231129_bf2f2303-19c6-4a93-b9ca-6efc1b445124.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSNbf2f2303-19c6-4a93-b9ca-6efc1b4451241016
199245glimepiride 1 MG Oral TabletSCDbf2f2303-19c6-4a93-b9ca-6efc1b4451241016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5650-16362956500130 TABLET in 1 BOTTLE (63629-5650-1) 30 tablet2015-05-280000-00-00NoNoCurrent
63629-5650-26362956500260 TABLET in 1 BOTTLE (63629-5650-2) 60 tablet2015-05-280000-00-00NoNoCurrent
63629-5650-36362956500390 TABLET in 1 BOTTLE (63629-5650-3) 90 tablet2015-05-280000-00-00NoNoCurrent
63629-5650-463629565004100 TABLET in 1 BOTTLE (63629-5650-4) 100 tablet2015-05-280000-00-00NoNoCurrent
63629-5650-56362956500520 TABLET in 1 BOTTLE (63629-5650-5) 20 tablet2015-05-280000-00-00NoNoCurrent