# HYDROXYUREA

NDC: 69315-164
Generic name: HYDROXYUREA
Labeler / Manufacturer: Leading Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: CAPSULE
Routes: ORAL
Marketing started: 20200709

FDA application: ANDA213438

## Active ingredients

- HYDROXYUREA: 500 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"69315-164"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=69315-164
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4c4e1c2f-2143-44f3-8825-aeba42e755e4