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
2398d418-6efc-b4d2-3265-936001df9b8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code16714-889
Application NumberANDA212040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ertapenem
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 28, 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