Active ingredient
Sepiapterin
4 finished FDA listings contain Sepiapterin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SEPIAPTERIN
- Dosage forms
- Powder
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 1000 mg/1 · 250 mg/1
- Brand names in FDA listings
- Sephience
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2723056
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 219666 | PTC THERAP | 2025-07-28 | 4 |
Official labeling on DailyMed
- SEPHIENCE (SEPIAPTERIN) POWDER [PTC THERAPEUTICS INC.] · version 6 · 2026-04-28
- SEPHIENCE (SEPIAPTERIN) POWDER [ALLPHAMED PHARBIL ARZNEIMITTEL GMBH] · version 1 · 2025-10-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.