# DROXIA

NDC: 80725-830
Generic name: Hydroxyurea
Labeler / Manufacturer: Waylis Therapeutics LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: CAPSULE
Routes: ORAL
Marketing started: 20250911

FDA application: NDA016295

## Active ingredients

- HYDROXYUREA: 300 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"80725-830"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=80725-830
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4ad13dc6-a2ab-4308-96b3-7c642c92cc23