# ROCTAVIAN

NDC: 68135-927
Generic name: valoctocogene roxaparvovec-rvox
Labeler / Manufacturer: BioMarin Pharmaceutical Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Biologic License Application
Dosage form: INJECTION, SUSPENSION
Routes: INTRAVENOUS
Marketing started: 20230629

FDA application: BLA125720

## Active ingredients

- VALOCTOCOGENE ROXAPARVOVEC: 20000000000000 {GC}/mL

## Pharmacological class

—

## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"68135-927"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=68135-927
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0dcf7185-8e1c-456a-9d4e-7cc316400118