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
b0075b72-c3cc-f844-e053-2a95a90a417f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Civica, Inc
DUNS: 081373942
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 Code72572-415
Application NumberANDA206086
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEROPENEM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 3, 2024
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 Code72572-416
Application NumberANDA206086
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEROPENEM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (2)
MEROPENEMActive
Quantity: 1 g in 30 mL
Code: FV9J3JU8B1
Classification: ACTIB
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT