Active ingredient
Sarecycline
3 finished FDA listings contain Sarecycline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SARECYCLINE HYDROCHLORIDE
- Dosage forms
- Tablet, Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/1 · 150 mg/1 · 60 mg/1
- Brand names in FDA listings
- Seysara
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2059018
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 209521 | ALMIRALL | 2018-10-01 | 3 |
Official labeling on DailyMed
- SEYSARA (SARECYCLINE HYDROCHLORIDE) TABLET, COATED [ALMIRALL, LLC] · version 12 · 2024-06-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.