# FABHALTA

NDC: 0078-1189
Generic name: iptacopan
Labeler / Manufacturer: Novartis Pharmaceuticals Corporation
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: CAPSULE
Routes: ORAL
Marketing started: 20231205

FDA application: NDA218276

## Active ingredients

- IPTACOPAN HYDROCHLORIDE: 200 mg/1

## Pharmacological class

—

## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0078-1189"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0078-1189
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a76b5845-6e21-4d3b-ad07-cd8df1b60bee