FDA.reportPublic FDA data

Glimepiride

Product NDC
21695-746
11-digit product format
216950746
Labeler code
21695
Product ID
21695-746_2001c00c-89ba-4d36-b39b-a5374a368427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
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
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
21695-746-302019-09-24C16284748780-1934fe258-4800-48b1-e053-8cdaa90a720aGlimepiride Tablets USP
21695-746-902019-09-24C16284748780-1934fe258-4800-48b1-e053-8cdaa90a720aGlimepiride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-746-30Glimepiride30 in 1 BOTTLETABLET302
21695-746-90Glimepiride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-746-30EA - Each21695-74608c5e741-ee12-405f-b7ac-5aba84d91c8412012-07-24
21695-746-90EA - Each21695-746529fbb3f-54bd-42be-85c0-02d5e87b9bde12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-746GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111118_3b20ae5e-9807-46c2-9de1-b64e76e61730.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199247glimepiride 4 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199245glimepiride 1 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199247glimepiride 4 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-746-302169507463030 in 1 BOTTLEHistorical
21695-746-902169507469090 in 1 BOTTLEHistorical