Glimepiride

Product NDC
68001-177
11-digit product format
680010177
Labeler code
68001
Product ID
68001-177_eff41a95-d73d-ed0a-e053-2995a90acfc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078181
Marketing category
ANDA
Marketing start
2014-02-26
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-177-00EA - Each68001-17764131b2a-e8c9-4123-abf5-e588996a1e3912014-05-02
68001-177-03EA - Each68001-1775f0105f6-b6f2-4b96-9608-18f27b92597312014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glimepirideACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
glimepirideACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-177GLIMEPIRIDE TABLET [BLUEPOINT LABORATORIES]13Legacy NDC20240223_d162c78f-d176-4150-8dda-2c4a5d215014.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-177-0068001017700100 TABLET in 1 BOTTLE (68001-177-00) 100 tablet2014-02-260000-00-00NoNoCurrent
68001-177-0368001017703500 TABLET in 1 BOTTLE (68001-177-03) 500 tablet2014-02-260000-00-00NoNoCurrent