roctavian

Generic: valoctocogene roxaparvovec-rvox

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name roctavian
Generic Name valoctocogene roxaparvovec-rvox
Labeler biomarin pharmaceutical inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

valoctocogene roxaparvovec 20000000000000 {GC}/mL

Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-927
Product ID 68135-927_baada118-a8a4-4c4b-bfd6-dee69373b520
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125720
Listing Expiration 2026-12-31
Marketing Start 2023-06-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68135927
Hyphenated Format 68135-927

Supplemental Identifiers

RxCUI
2641614 2641620
UNII
681K1JDI8M

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 roctavian (source: ndc)
Generic Name valoctocogene roxaparvovec-rvox (source: ndc)
Application Number BLA125720 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20000000000000 {GC}/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68135-927-48) / 8 mL in 1 VIAL (68135-927-01)
source: ndc

Packages (1)

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

Ingredients (1)

valoctocogene roxaparvovec (20000000000000 {GC}/mL)

Linked Drug Pages (1)

ROCTAVIAN ndc-match (0.9)

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"}