Meropenem
These highlights do not include all the information needed to use MEROPENEM FOR INJECTION (I.V.) safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION (I.V.)MEROPENEM FOR INJECTION, USP (I.V.), for intravenous useInitial U.S. Approval: 1996
Approved
Approval ID
185181e3-c004-4d61-b992-5df94fe57a90
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meropenem
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-507
Application NumberANDA091404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2019
FDA Product Classification
INGREDIENTS (1)
MEROPENEMActive
Quantity: 500 mg in 10 mL
Code: FV9J3JU8B1
Classification: ACTIB
Meropenem
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-508
Application NumberANDA091404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2019
FDA Product Classification
INGREDIENTS (1)
MEROPENEMActive
Quantity: 1 g in 20 mL
Code: FV9J3JU8B1
Classification: ACTIB