MEROPENEM
These highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION. MEROPENEM for injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
06d84c55-94ff-46e5-8477-b8881c12eb0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2021
Manufacturers
FDA
Xellia Pharmaceuticals USA LLC
DUNS: 116768762
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 Code70594-076
Application NumberANDA206141
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEROPENEM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2021
FDA Product Classification
INGREDIENTS (1)
MEROPENEMActive
Quantity: 1 g in 30 mL
Code: FV9J3JU8B1
Classification: ACTIB
MEROPENEM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70594-075
Application NumberANDA206141
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEROPENEM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2021
FDA Product Classification
INGREDIENTS (1)
MEROPENEMActive
Quantity: 500 mg in 20 mL
Code: FV9J3JU8B1
Classification: ACTIB