ertapenem sodium
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
a400707f-763f-43f6-989e-0d2569d822d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA, Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ertapenem sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9398
Application NumberANDA208790
Product Classification
M
Marketing Category
C73584
G
Generic Name
ertapenem sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateFebruary 26, 2021
FDA Product Classification
INGREDIENTS (3)
ERTAPENEM SODIUMActive
Quantity: 1 g in 1 1
Code: 2T90KE67L0
Classification: ACTIM
sodium bicarbonateInactive
Quantity: 175 mg in 1 1
Code: 8MDF5V39QO
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT