Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Roche Singapore Technical Operations Pte. Ltd.
Genentech, Inc.
937189173
Roche Diagnostics GmbH
Genentech, Inc.
315028860
Genentech, Inc.
Genentech, Inc.
146373191
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Herceptin
Product Details
NDC Product Code
50242-132Application Number
BLA103792Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
October 19, 2020HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 3.4 mg in 7.4 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
TrastuzumabActive
Code: P188ANX8CKClass: ACTIBQuantity: 150 mg in 7.4 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT