HERZUMA
These highlights do not include all the information needed to use HERZUMA safely and effectively. See full prescribing information for HERZUMA. HERZUMA (trastuzumab-pkrb) for injection, for intravenous use Initial U.S. Approval: 2018 HERZUMA (trastuzumab-pkrb) is biosimilar to HERCEPTIN (trastuzumab).
Approved
Approval ID
ae71c003-883a-4cd8-ad50-e8cc9a54e971
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
Cephalon, Inc.
DUNS: 183236314
Products 2
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 Code63459-303
Application NumberBLA761091
Product Classification
M
Marketing Category
C73585
G
Generic Name
TRASTUZUMAB
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 6, 2023
FDA Product Classification
INGREDIENTS (5)
TRASTUZUMABActive
Quantity: 150 mg in 7.15 mL
Code: P188ANX8CK
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 299.6 mg in 7.15 mL
Code: 7YIN7J07X4
Classification: IACT
HISTIDINEInactive
Quantity: 2.2 mg in 7.15 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.6 mg in 7.15 mL
Code: 7T1F30V5YH
Classification: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Quantity: 3.4 mg in 7.15 mL
Code: 1D5Q932XM6
Classification: IACT
TRASTUZUMAB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-305
Application NumberBLA761091
Product Classification
M
Marketing Category
C73585
G
Generic Name
TRASTUZUMAB
Product Specifications
Effective DateFebruary 6, 2023
FDA Product Classification
Drug Labeling Information
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 12/11/2024
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 12/11/2024
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 11/25/2024
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 12/11/2024
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/28/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/11/2024