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GLIMEPIRIDE

GLIMEPIRIDE

Approved
Approval ID

2b57dfa7-f2c2-45ca-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 2023

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GLIMEPIRIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61919-250
Application NumberANDA078181
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLIMEPIRIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLIMEPIRIDEActive
Quantity: 4 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/4/2016

1 INDICATIONS AND USAGE

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1)].

Limitations of Use

Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 2/4/2016

10 OVERDOSAGE

An overdosage of glimepiride, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies requiring immediate treatment. Severe hypoglycemia with coma, seizure, or neurological impairment can be treated with glucagon or intravenous glucose. Continued observation and additional carbohydrate intake may be necessary because hypoglycemia may recur after apparent clinical recovery [see Warnings and Precautions ( 5.1) ]

DESCRIPTION SECTION

LOINC: 34089-3Updated: 2/4/2016

11 DESCRIPTION

Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1­carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.

The structural formula is:

[Structure]

Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, sodium starch glycolate, povidone, and magnesium stearate. In addition, glimepiride tablets, USP 1 mg contain ferric oxide red, glimepiride tablets, USP 2 mg contain ferric oxide yellow and FD &C blue #2 aluminum lake, and glimepiride tablets, USP 4 mg contain FD&C blue #2 aluminum lake.

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GLIMEPIRIDE - FDA Drug Approval Details