Glimepiride

Product NDC
50436-7073
11-digit product format
504367073
Labeler code
50436
Product ID
50436-7073_801a83ed-376d-4875-8055-7bd93d02e4ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
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
50436-7073-1Glimepiride30 in 1 BOTTLETABLET3010
50436-7073-3Glimepiride90 in 1 BOTTLETABLET9010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7073GLIMEPIRIDE TABLET [UNIT DOSE SERVICES]10Legacy NDC, 2 package rows20190425_b5c912bf-d1b3-4c65-9049-0d91a382d236.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNb5c912bf-d1b3-4c65-9049-0d91a382d23610
199246glimepiride 2 MG Oral TabletSCDb5c912bf-d1b3-4c65-9049-0d91a382d23610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7073-15043670730130 in 1 BOTTLEHistorical
50436-7073-35043670730390 in 1 BOTTLEHistorical