FDA.reportPublic FDA data

Glimepiride

Product NDC
10544-217
11-digit product format
105440217
Labeler code
10544
Product ID
10544-217_10797255-7883-4f66-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077091
Marketing category
ANDA
Marketing start
2013-10-08
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-217-302020-01-31C16284748780-19d75b9d0-b2e1-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
10544-217-30Glimepiride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-217-30EA - Each10544-217407762db-7938-4c74-b584-8e898ac3a8e412015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-217GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150304_e2ed9eeb-e67d-485f-86cb-eb9061bd9d96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletPSNe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199246glimepiride 2 MG Oral TabletSCDe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletSCDe2ed9eeb-e67d-485f-86cb-eb9061bd9d962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-217-301054402173030 in 1 BOTTLEHistorical