Home NDC 65597-406 Enhertu
Product NDC 65597-406
11-digit product format 655970406
Labeler code 65597
Product ID 65597-406_a4106ba4-f398-4663-980c-2b7195283edd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fam-trastuzumab deruxtecan-nxki
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Daiichi Sankyo Inc.
Application BLA761139
Marketing category BLA
Marketing start 2019-12-20
Substance TRASTUZUMAB DERUXTECAN
Active strength 100 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Enhertu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRASTUZUMAB DERUXTECAN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5384HK7574 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2267576 Internal RxNorm lookup 2267581 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65597-406-01 Enhertu 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 28 65597-406-01 Enhertu 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65597-406 ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DAIICHI SANKYO INC.] 21 Current NDC, Legacy NDC, 2 package rows 20250522_7e67e73e-ddf4-4e4d-8b50-09d7514910b6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Enhertu FAM-TRASTUZUMAB DERUXTECAN-NXKI Daiichi Sankyo Inc. 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 2026-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761139 ndc (product): 65597-406
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761139 Enhertu fam-trastuzumab deruxtecan-nxki 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65597-406-01 65597040601 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2019-12-20 0000-00-00 No No Current