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 useInitial U.S. Approval: 2001
Approved
Approval ID
41304b1d-7db4-468a-ab1d-04e56fb50de4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
Manufacturers
FDA
Par Pharmaceutical Inc.
DUNS: 092733690
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 Code42023-221
Application NumberNDA021337
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertapenem sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 7, 2022
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