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
6520ae3d-e149-499c-8152-36f6ab861662
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2021
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-146
Application NumberANDA210773
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (3)
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM
MEROPENEMActive
Quantity: 1 g in 1 1
Code: FV9J3JU8B1
Classification: ACTIB
SODIUM CARBONATEInactive
Quantity: 90.2 mg in 1 1
Code: 45P3261C7T
Classification: IACT
Meropenem
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-145
Application NumberANDA210773
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2021
FDA Product Classification
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