Glimepiride

Product NDC
69543-125
11-digit product format
695430125
Labeler code
69543
Product ID
69543-125_d8f2bca6-5e18-4a1f-b782-9b6e7ba83bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
ANDA202112
Marketing category
ANDA
Marketing start
2015-07-14
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-125-10EA - Each69543-125b4c533dc-1a89-4579-9be8-c009fba7822712015-08-04
69543-125-50EA - Each69543-12527687398-723b-4c4a-857b-7ac2ecc5ae0512015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlimepirideACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
GlimepirideACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-125GLIMEPIRIDE TABLET [VIRTUS PHARMACEUTICALS]3Legacy NDC20190403_4419ca50-539c-47e8-ab00-dbb45c7c1814.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-125-1069543012510100 TABLET in 1 BOTTLE (69543-125-10) 100 tablet2015-07-140000-00-00NoNoCurrent
69543-125-5069543012550500 TABLET in 1 BOTTLE (69543-125-50) 500 tablet2015-07-140000-00-00NoNoCurrent