MARGENZA
These highlights do not include all the information needed to use MARGENZA safely and effectively. See full prescribing information for MARGENZA. MARGENZA (margetuximab-cmkb) injection, for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
e97a5872-eabf-463b-8f4c-5b5aed9c7bf0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 30, 2023
Manufacturers
FDA
MacroGenics, Inc
DUNS: 010626351
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
margetuximab-cmkb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code74527-022
Application NumberBLA761150
Product Classification
M
Marketing Category
C73585
G
Generic Name
margetuximab-cmkb
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 30, 2023
FDA Product Classification
INGREDIENTS (8)
MARGETUXIMABActive
Quantity: 25 mg in 1 mL
Code: K911R84KEW
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20Y
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT