# sapropterin dihydrochloride

NDC: 0054-0906
Generic name: sapropterin dihydrochloride
Labeler / Manufacturer: Hikma Pharmaceuticals USA Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20251023

FDA application: ANDA218797

## Active ingredients

- SAPROPTERIN DIHYDROCHLORIDE: 100 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0054-0906"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0054-0906
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c4d92cce-e899-4f14-b19c-5e17f9922215