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Glimepiride

These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral use Initial U.S. Approval: 1995

Approved
Approval ID

9b74fbac-9e04-4927-9981-1e3dace89c6d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2023

Manufacturers
FDA

Accord Healthcare Inc

DUNS: 604222237

Products 3

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 Code16729-003
Application NumberANDA078181
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification

INGREDIENTS (6)

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

Glimepiride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-001
Application NumberANDA078181
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification

INGREDIENTS (6)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLIMEPIRIDEActive
Quantity: 1 mg in 1 1
Code: 6KY687524K
Classification: ACTIB

Glimepiride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-002
Application NumberANDA078181
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification

INGREDIENTS (7)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLIMEPIRIDEActive
Quantity: 2 mg in 1 1
Code: 6KY687524K
Classification: ACTIB

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Glimepiride - FDA Drug Approval Details