Ertapenem
These highlights do not include all the information needed to use ERTAPENEM FOR INJECTION safely and effectively. See full prescribing information for ERTAPENEM FOR INJECTION. ERTAPENEM for injection, for intravenous or intramuscular use Initial U.S. Approval: 2001
Approved
Approval ID
31bcf16f-e0c1-47d1-9852-de898a856f6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ertapenem
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-282
Application NumberANDA209133
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ertapenem
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 23, 2023
FDA Product Classification
INGREDIENTS (3)
ERTAPENEM SODIUMActive
Quantity: 1 g in 1 1
Code: 2T90KE67L0
Classification: ACTIM
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT