# ORFADIN

NDC: 66658-204
Generic name: nitisinone
Labeler / Manufacturer: Swedish Orphan Biovitrum AB (publ)
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: SUSPENSION
Routes: ORAL
Marketing started: 20160601

FDA application: NDA206356

## Active ingredients

- NITISINONE: 4 mg/mL

## Pharmacological class

—

## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"66658-204"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=66658-204
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=00307f42-748d-4227-8c6f-ed5f0a89ae0a