Enhertu

Basic Information

Product Name

Enhertu

FDA Product Code

65597-406

Regulatory Information

NDC Product Code

65597-406

Application Number

BLA761139

Marketing Category

C73585

Effective Date

February 22, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ENHERTU safely and effectively. See full prescribing information for ENHERTU. ENHERTU (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U.S. Approval: 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TRASTUZUMAB DERUXTECAN

Quantity: 100 mg in 5 mL

Code: 5384HK7574

Class Code: ACTIB

HISTIDINE

Code: 4QD397987E

Class Code: IACT

HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE

Code: X573657P6P

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

Active Moieties

TRASTUZUMAB DERUXTECAN

Code: 5384HK7574

Basic Information

Regulatory Information

Company Information

Active Ingredients

HISTIDINE

HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE

POLYSORBATE 80

SUCROSE

Active Moieties

TRASTUZUMAB DERUXTECAN