FDA.reportPublic FDA data

Glimepiride

Product NDC
53217-250
11-digit product format
532170250
Labeler code
53217
Product ID
53217-250_cd9c6208-53c4-46c5-9009-486ddd92d895
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
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
53217-250-302020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
53217-250-602020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
53217-250-902020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
53217-250-992020-01-31C16284748780-19d75b9d0-9d0c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-250-30Glimepiride30 in 1 BOTTLETABLET301
53217-250-60Glimepiride60 in 1 BOTTLETABLET601
53217-250-90Glimepiride90 in 1 BOTTLETABLET901
53217-250-99Glimepiride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-250-30EA - Each53217-2507f9af054-ec46-4e83-b639-0bfcd49f662112016-12-07
53217-250-60EA - Each53217-250128509b1-da53-40e2-9410-fd454ad52d0912016-12-07
53217-250-90EA - Each53217-250bf65f10c-acb5-4a06-b106-5fdefa1dea4912016-12-07
53217-250-99EA - Each53217-2506cc6206a-6c50-45f1-8450-cf0309b7adbe12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-250GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161202_feeb6508-bad3-428d-8a76-ddc55793b109.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNfeeb6508-bad3-428d-8a76-ddc55793b1091
199246glimepiride 2 MG Oral TabletSCDfeeb6508-bad3-428d-8a76-ddc55793b1091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-250-305321702503030 in 1 BOTTLEHistorical
53217-250-605321702506060 in 1 BOTTLEHistorical
53217-250-905321702509090 in 1 BOTTLEHistorical
53217-250-9953217025099180 in 1 BOTTLEHistorical