Active ingredient
Selegiline
17 finished FDA listings contain Selegiline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SELEGILINE, SELEGILINE HYDROCHLORIDE
- Dosage forms
- Capsule, Patch, Tablet, Tablet, Orally Disintegrating
- Routes
- Oral, Transdermal
- Manufacturers / labelers
- 13
- Strengths listed
- 1.25 mg/1 · 12 mg/24h · 5 mg/1 · 6 mg/24h · 9 mg/24h
- Brand names in FDA listings
- Emsam, Zelapar
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9639
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 |
|---|---|---|---|
| ANDA 074565 | CHARTWELL MOLECULES | 1996-08-02 | 1 |
| ANDA 074672 | PHARMAZONE | 1997-04-01 | 2 |
| ANDA 074871 | APOTEX | 1997-06-06 | 3 |
| ANDA 075352 | NOVITIUM PHARMA | 1998-11-30 | 3 |
| ANDA 075321 | APOTEX | 1998-12-04 | 1 |
| NDA 021336 | SOMERSET | 2006-02-27 | 3 |
| NDA 021479 | BAUSCH | 2006-06-14 | 1 |
| ANDA 206803 | RISING | 2019-04-02 | 3 |
Official labeling on DailyMed
- ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [BAUSCH HEALTH US, LLC] · version 13 · 2026-06-29
- SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 10 · 2025-12-08
- SELEGILINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS, INC.] · version 4 · 2025-11-24
- SELEGILINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 1 · 2025-08-20
- SELEGILINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 1 · 2025-07-17
- SELEGILINE HYDROCHLORIDE TABLET [A2A INTEGRATED PHARMACEUTICALS] · version 2 · 2025-04-28
- EMSAM (SELEGILINE) PATCH [VIATRIS SPECIALTY LLC] · version 17 · 2025-02-10
- SELEGILINE HYDROCHLORIDE TABLET [I3 PHARMACEUTICALS, LLC] · version 5 · 2024-11-18
- SELEGILINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.] · version 3 · 2024-08-09
- SELEGILINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] · version 1 · 2024-05-09
- SELEGILINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] · version 9 · 2023-02-08
- SELEGILINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP] · version 2 · 2022-04-15
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.