Package 65597-801-01

Brand: datroway

Generic: datopotamab deruxtecan
NDC Package

Package Facts

Identity

Package NDC 65597-801-01
Digits Only 6559780101
Product NDC 65597-801
Product ID 65597-801_d539242b-120c-41a7-b36f-e6b446e4712c
Description

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

Marketing

Marketing Status
Marketed Since 2025-01-17
Brand datroway
Generic datopotamab deruxtecan
Sample Package No

Linked Drug Pages (1)

DATROWAY ndc-match (0.95)

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"}