Medicine
Protriptyline 5 mg tablet
Protriptyline 5 mg tablet is a generic prescription medicine for oral use, made by 2 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 20°-25°C (68°-77°F).
Key facts
- Active ingredient (INN)
- Protriptyline
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 1 more
- Manufacturers
- Epic PharmaSigmapharm Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AA11 Protriptyline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 January 2013
- Identifiers
- RxCUI 905168, 905172DailyMed set ID c6c7c39e-e510-4f4a-bf7a-926f0e075d3a, a023e637-bee9-8c86-e053-2a95a90aa488NDC 42806-096, 42794-004Application ANDA202220, ANDA090462
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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 42806-096-01 | Epic Pharma | 9 January 2013 |
| 1000 tablet, film coated in 1 bottle | 42806-096-10 | Epic Pharma | 9 January 2013 |
| 30 tablet, film coated in 1 bottle | 42806-096-30 | Epic Pharma | 10 July 2020 |
| 100 tablet, film coated in 1 bottle | 42794-004-02 | Sigmapharm Laboratories | 2 March 2020 |
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 27 September 1967 | 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 Protriptyline
Clinical summary
Protriptyline is a tricyclic antidepressant indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. It is available as tablets for oral use. MedsAcross supplies Protriptyline 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 ProtriptylineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Protriptyline Hydrochloride prescribing information (Epic Pharma) · U.S. National Library of Medicine, DailyMed
Need Protriptyline 5 mg tablet 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.