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
ca5f501c-6520-4d09-aae2-4f5db74d468f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2019
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
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 Code68001-323
Application NumberANDA205883
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 22, 2019
FDA Product Classification
INGREDIENTS (2)
MEROPENEMActive
Quantity: 500 mg in 20 mL
Code: FV9J3JU8B1
Classification: ACTIB
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
Meropenem
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-324
Application NumberANDA205883
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meropenem
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 22, 2019
FDA Product Classification
INGREDIENTS (2)
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MEROPENEMActive
Quantity: 1 g in 30 mL
Code: FV9J3JU8B1
Classification: ACTIB