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 (IV) or intramuscular (IM) use Initial U.S. Approval: 2001
Approved
Approval ID
32d9f095-ca39-7e22-6264-b54f2daaee57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
Dr.Reddys Laboratories Inc.,
DUNS: 802315887
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 Code43598-901
Application NumberANDA212040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ertapenem
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 8, 2021
FDA Product Classification
INGREDIENTS (3)
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Ertapenem SodiumActive
Quantity: 1 g in 1 1
Code: 2T90KE67L0
Classification: ACTIM