enhertu

Generic: fam-trastuzumab deruxtecan-nxki

Labeler: daiichi sankyo inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name enhertu
Generic Name fam-trastuzumab deruxtecan-nxki
Labeler daiichi sankyo inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

trastuzumab deruxtecan 100 mg/5mL

Manufacturer
Daiichi Sankyo Inc.

Identifiers & Regulatory

Product NDC 65597-406
Product ID 65597-406_80e10523-61aa-4370-8e95-9a4de6177e7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761139
Listing Expiration 2026-12-31
Marketing Start 2019-12-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65597406
Hyphenated Format 65597-406

Supplemental Identifiers

RxCUI
2267576 2267581
UNII
5384HK7574

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name enhertu (source: ndc)
Generic Name fam-trastuzumab deruxtecan-nxki (source: ndc)
Application Number BLA761139 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65597-406-01 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

trastuzumab deruxtecan (100 mg/5mL)

Linked Drug Pages (1)

Enhertu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "80e10523-61aa-4370-8e95-9a4de6177e7e", "openfda": {"unii": ["5384HK7574"], "rxcui": ["2267576", "2267581"], "spl_set_id": ["7e67e73e-ddf4-4e4d-8b50-09d7514910b6"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65597-406-01", "marketing_start_date": "20191220"}], "brand_name": "Enhertu", "product_id": "65597-406_80e10523-61aa-4370-8e95-9a4de6177e7e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "65597-406", "generic_name": "fam-trastuzumab deruxtecan-nxki", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enhertu", "active_ingredients": [{"name": "TRASTUZUMAB DERUXTECAN", "strength": "100 mg/5mL"}], "application_number": "BLA761139", "marketing_category": "BLA", "marketing_start_date": "20191220", "listing_expiration_date": "20261231"}