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
092ebd9b-77a0-4877-afc3-dd8211730f71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-1390
Application NumberANDA091404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 9, 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 Code0409-1391
Application NumberANDA091404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 9, 2019
FDA Product Classification
INGREDIENTS (1)
MEROPENEMActive
Quantity: 1 g in 20 mL
Code: FV9J3JU8B1
Classification: ACTIB