datroway

Generic: datopotamab deruxtecan

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

Drug Facts

Product Profile

Brand Name datroway
Generic Name datopotamab deruxtecan
Labeler daiichi sankyo inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

datopotamab deruxtecan 100 mg/5mL

Manufacturer
Daiichi Sankyo Inc.

Identifiers & Regulatory

Product NDC 65597-801
Product ID 65597-801_d539242b-120c-41a7-b36f-e6b446e4712c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761394
Listing Expiration 2027-12-31
Marketing Start 2025-01-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65597801
Hyphenated Format 65597-801

Supplemental Identifiers

RxCUI
2703040 2703046
UNII
GD2OWY1DTK

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 datroway (source: ndc)
Generic Name datopotamab deruxtecan (source: ndc)
Application Number BLA761394 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65597-801-01 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

datopotamab deruxtecan (100 mg/5mL)

Linked Drug Pages (1)

DATROWAY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d539242b-120c-41a7-b36f-e6b446e4712c", "openfda": {"unii": ["GD2OWY1DTK"], "rxcui": ["2703040", "2703046"], "spl_set_id": ["2950227c-6230-4ca4-a135-46e44d9424a0"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65597-801-01", "marketing_start_date": "20250117"}], "brand_name": "DATROWAY", "product_id": "65597-801_d539242b-120c-41a7-b36f-e6b446e4712c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "65597-801", "generic_name": "Datopotamab Deruxtecan", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DATROWAY", "active_ingredients": [{"name": "DATOPOTAMAB DERUXTECAN", "strength": "100 mg/5mL"}], "application_number": "BLA761394", "marketing_category": "BLA", "marketing_start_date": "20250117", "listing_expiration_date": "20271231"}