PERJETA
These highlights do not include all the information needed to use PERJETA safely and effectively. See full prescribing information for PERJETA. PERJETA (pertuzumab) injection, for intravenous use Initial U.S. Approval: 2012
Approved
Approval ID
17f85d17-ab71-4f5b-9fe3-0b8c822f69ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2020
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pertuzumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-145
Application NumberBLA125409
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pertuzumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2020
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
PERTUZUMABActive
Quantity: 30 mg in 1 mL
Code: K16AIQ8CTM
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT