FDA.reportPublic FDA data

GLIMEPIRIDE

Product NDC
54458-966
11-digit product format
544580966
Labeler code
54458
Product ID
54458-966_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
4 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54458-966-102024-01-30C16284748780-11030e365-2c3a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995
54458-966-162024-01-30C16284748780-11030e365-2c3a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-966-10GLIMEPIRIDE30 in 1 BLISTER PACKTABLET3041
54458-966-16GLIMEPIRIDE30 in 1 BOTTLETABLET3041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-966-10EA - Each54458-966cc9358d2-6b66-4e1f-89b2-dbfa32093f6a12012-07-24
54458-966-16EA - Each54458-966e27827fb-c7ac-4265-adb2-ace4ccd4046c12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [INTERNATIONAL LABORATORIES, INC.]34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-966GLIMEPIRIDE 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
54458-966-105445809661030 TABLET in 1 BLISTER PACK (54458-966-10) 30 tablet2009-02-060000-00-00NoNoCurrent
54458-966-165445809661630 TABLET in 1 BOTTLE (54458-966-16) 30 tablet2017-07-170000-00-00NoNoCurrent