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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

06d84c55-94ff-46e5-8477-b8881c12eb0a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 8, 2021

Manufacturers
FDA

Xellia Pharmaceuticals USA LLC

DUNS: 116768762

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 Code70594-076
Application NumberANDA206141
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEROPENEM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2021
FDA Product Classification

INGREDIENTS (1)

MEROPENEMActive
Quantity: 1 g in 30 mL
Code: FV9J3JU8B1
Classification: ACTIB

MEROPENEM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-075
Application NumberANDA206141
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEROPENEM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2021
FDA Product Classification

INGREDIENTS (1)

MEROPENEMActive
Quantity: 500 mg in 20 mL
Code: FV9J3JU8B1
Classification: ACTIB

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MEROPENEM - FDA Drug Approval Details