Glimepiride
These highlights do not include all the information needed to use glimepiride safely and effectively. See full prescribing information for glimepiride. GLIMEPIRIDE Tablets USP for oral use Initial U.S. Approval: 1995
Approved
Approval ID
5a5747ea-cded-49ed-8807-dd3e2a1159e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-698
Application NumberANDA078181
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glimepiride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLIMEPIRIDEActive
Quantity: 1 mg in 1 1
Code: 6KY687524K
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT