Package 68135-927-48

Brand: roctavian

Generic: valoctocogene roxaparvovec-rvox
NDC Package

Package Facts

Identity

Package NDC 68135-927-48
Digits Only 6813592748
Product NDC 68135-927
Product ID 68135-927_baada118-a8a4-4c4b-bfd6-dee69373b520
Description

1 VIAL in 1 CARTON (68135-927-48) / 8 mL in 1 VIAL (68135-927-01)

Marketing

Marketing Status
Marketed Since 2023-06-29
Brand roctavian
Generic valoctocogene roxaparvovec-rvox
Sample Package No

Linked Drug Pages (1)

ROCTAVIAN ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "baada118-a8a4-4c4b-bfd6-dee69373b520", "openfda": {"unii": ["681K1JDI8M"], "rxcui": ["2641614", "2641620"], "spl_set_id": ["0dcf7185-8e1c-456a-9d4e-7cc316400118"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68135-927-48)  / 8 mL in 1 VIAL (68135-927-01)", "package_ndc": "68135-927-48", "marketing_start_date": "20230629"}], "brand_name": "ROCTAVIAN", "product_id": "68135-927_baada118-a8a4-4c4b-bfd6-dee69373b520", "dosage_form": "INJECTION, SUSPENSION", "product_ndc": "68135-927", "generic_name": "valoctocogene roxaparvovec-rvox", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROCTAVIAN", "active_ingredients": [{"name": "VALOCTOCOGENE ROXAPARVOVEC", "strength": "20000000000000 {GC}/mL"}], "application_number": "BLA125720", "marketing_category": "BLA", "marketing_start_date": "20230629", "listing_expiration_date": "20261231"}