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 useInitial U.S. Approval: 1996
Approved
Approval ID
74ff19b5-6156-4a27-affb-744b0ce1aeec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 29, 2020
Manufacturers
FDA
WG Critical Care, LLC
DUNS: 829274633
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meropenem
PRODUCT DETAILS
NDC Product Code44567-400
Application NumberANDA210773
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 1, 2020
Generic NameMeropenem
INGREDIENTS (3)
MEROPENEMActive
Quantity: 500 mg in 1 1
Code: FV9J3JU8B1
Classification: ACTIB
SODIUM CARBONATEInactive
Quantity: 45.1 mg in 1 1
Code: 45P3261C7T
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM
Meropenem
PRODUCT DETAILS
NDC Product Code44567-401
Application NumberANDA210773
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 1, 2020
Generic NameMeropenem
INGREDIENTS (3)
SODIUM CARBONATEInactive
Quantity: 90.2 mg in 1 1
Code: 45P3261C7T
Classification: IACT
MEROPENEMActive
Quantity: 1 g in 1 1
Code: FV9J3JU8B1
Classification: ACTIB
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM