Ontruzant
These highlights do not include all the information needed to use ONTRUZANT safely and effectively. See full prescribing information for ONTRUZANT. ONTRUZANT (trastuzumab-dttb) for injection, for intravenous use Initial U.S. Approval: 2019 ONTRUZANT (trastuzumab-dttb) is biosimilar to HERCEPTIN (trastuzumab)
Approved
Approval ID
ce2a2492-85e3-4b0a-872a-047f44e4203d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Organon LLC
DUNS: 117494753
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 Code78206-147
Application NumberBLA761100
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (5)
trastuzumabActive
Quantity: 150 mg in 1 1
Code: P188ANX8CK
Classification: ACTIB
histidine monohydrochloride monohydrateInactive
Quantity: 3.4 mg in 1 1
Code: X573657P6P
Classification: IACT
histidineInactive
Quantity: 2.2 mg in 1 1
Code: 4QD397987E
Classification: IACT
polysorbate 20Inactive
Quantity: 0.6 mg in 1 1
Code: 7T1F30V5YH
Classification: IACT
trehalose dihydrateInactive
Quantity: 136.2 mg in 1 1
Code: 7YIN7J07X4
Classification: IACT
Ontruzant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78206-148
Application NumberBLA761100
Product Classification
M
Marketing Category
C73585
G
Generic Name
Ontruzant
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
FDA Product Classification
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 6/11/2021
**WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and
PULMONARY TOXICITY**