Medicine
Selegiline 5 mg capsule
Selegiline 5 mg capsule is a generic prescription medicine for oral use, made by 6 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20º to 25 ºC (68º to 77ºF ).
Key facts
- Active ingredient (INN)
- Selegiline
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 1000 capsules, 500 capsules and 13 more
- Manufacturers
- Proficient RxApotexBryant Ranch PrepackNovitium PharmaRising Pharma HoldingsMarlex Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25 ºC (68º to 77ºF ).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BD01 Selegiline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 July 1997
- Identifiers
- RxCUI 859186DailyMed set ID e42d99b0-c62e-49d4-b792-1301bb539b92, 57b564ef-c89b-4cf6-a11f-f67391d74e7e, b8eb0a00-adc7-4aaf-987c-fa1b207b2996 +4NDC 70954-504, 71205-888, 71335-2676 +4Application ANDA075352, ANDA206803, ANDA075321
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule in 1 bottle | 60505-0055-1 | Apotex | 15 July 1997 |
| 1000 capsule in 1 bottle | 60505-0055-2 | Apotex | 15 July 1997 |
| 500 capsule in 1 bottle | 60505-0055-3 | Apotex | 15 July 1997 |
| 60 capsule in 1 bottle | 70954-504-10 | Novitium Pharma | 1 April 2021 |
| 1000 capsule in 1 bottle | 70954-504-20 | Novitium Pharma | 1 April 2021 |
| 60 capsule in 1 bottle | 16571-659-06 | Rising Pharma Holdings | 2 April 2019 |
| 500 capsule in 1 bottle | 16571-659-50 | Rising Pharma Holdings | 2 April 2019 |
| 30 capsule in 1 bottle | 71335-2673-1 | Bryant Ranch Prepack | 15 July 2025 |
| 30 capsule in 1 bottle | 71335-2676-1 | Bryant Ranch Prepack | 18 August 2025 |
| 60 capsule in 1 bottle | 10135-737-60 | Marlex Pharmaceuticals | 1 May 2021 |
| 100 capsule in 1 bottle | 71205-888-00 | Proficient Rx | 3 August 2021 |
| 1000 capsule in 1 bottle | 71205-888-11 | Proficient Rx | 3 August 2021 |
| 30 capsule in 1 bottle | 71205-888-30 | Proficient Rx | 3 August 2021 |
| 500 capsule in 1 bottle | 71205-888-55 | Proficient Rx | 3 August 2021 |
| 60 capsule in 1 bottle | 71205-888-60 | Proficient Rx | 3 August 2021 |
| 90 capsule in 1 bottle | 71205-888-90 | Proficient Rx | 3 August 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 5 June 1989 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Selegiline
Clinical summary
Selegiline is a monoamine oxidase inhibitor indicated for the treatment of adults with major depressive disorder (MDD). It is available as capsules, tablets and transdermal patches for oral use. MedsAcross supplies Selegiline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about SelegilineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- EMSAM prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Selegiline 5 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.