Glimepiride
These highlights do not include all the information needed to use Glimepiride safely and effectively. See full prescribing information for Glimepiride Tablets, USP. Glimepiride Tablets, USP Initial U.S. Approval: 1995
Approved
Approval ID
72d88c6d-2f0a-4bf8-aa7f-1e1811794187
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2022
Manufacturers
FDA
Carlsbad Technology, Inc.
DUNS: 781047246
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 Code61442-117
Application NumberANDA077911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification
INGREDIENTS (7)
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
GLIMEPIRIDEActive
Quantity: 4 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Glimepiride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-116
Application NumberANDA077911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
GLIMEPIRIDEActive
Quantity: 2 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
Glimepiride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-115
Application NumberANDA077911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLIMEPIRIDEActive
Quantity: 1 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT