Herceptin
These highlights do not include all the information needed to use Herceptin safely and effectively. See full prescribing information for Herceptin. HERCEPTIN (trastuzumab)for injection, for intravenous useInitial U.S. Approval: 1998
Approved
Approval ID
492dbdb2-077e-4064-bff3-372d6af0a7a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 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.
Trastuzumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-132
Application NumberBLA103792
Product Classification
M
Marketing Category
C73585
G
Generic Name
Trastuzumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 19, 2020
FDA Product Classification
INGREDIENTS (5)
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 3.4 mg in 7.4 mL
Code: X573657P6P
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
TRASTUZUMABActive
Quantity: 150 mg in 7.4 mL
Code: P188ANX8CK
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT