Enhertu (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 100 mg Vial Carton

NDC 65597-406-01
Rx only

ENHERTU®
(fam-trastuzumab deruxtecan-nxki)

For Injection

100 mg per vial

For Intravenous Infusion Only
Dispense the enclosed Medication Guide to each patient.
Reconstitute and Dilute prior to administration
Single-Dose Vial
Discard Unused Portion

Hazardous Drug

KEEP REFRIGERATED

1 vial

Daiichi-SankyoAstraZeneca

PRINCIPAL DISPLAY PANEL -- 100 mg Vial Carton
(click image for full-size original)
ENHERTU fam-trastuzumab deruxtecan-nxki injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-406
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRASTUZUMAB DERUXTECAN (TRASTUZUMAB DERUXTECAN) TRASTUZUMAB DERUXTECAN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
SUCROSE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-406-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (65597-406-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761139 12/20/2019
Labeler — Daiichi Sankyo, Inc. (068605067)

Revised: 05/2022 Daiichi Sankyo, Inc.

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