Medicine
Amitriptyline 50 mg tablet
Amitriptyline 50 mg tablet is a generic prescription medicine for oral use, made by 28 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Amitriptyline
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 100 tablets, 500 tablets and 127 more
- Manufacturers
- Zydus LifesciencesIndiaUnichem LaboratoriesIndiaAurobindo PharmaIndiaLifestar PharmaIndiaSun Pharmaceutical IndustriesIndiaCentaur PharmaceuticalsIndiaA-S Medication SolutionsAdvagen PharmaAiPing PharmaceuticalRising Pharma Holdings28 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AA09 Amitriptyline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 November 1977
- Identifiers
- RxCUI 856783, 856834, 856845 +3DailyMed set ID 4e0f3b15-3621-48a1-9f2b-b0a373920360, 1f40216a-3db1-49a7-b717-59dfa72bc182, 6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa8 +37NDC 71610-711, 50090-8135, 68788-8363 +37Application ANDA089399, ANDA212654, ANDA214548 +7
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
A sample of 40 packs from 28 labelers. The register lists 130 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1000 tablet, film coated in 1 bottle | 70710-1227-0 | Zydus LifesciencesIndia | 26 December 2017 |
| 100 tablet, film coated in 1 bottle | 70710-1227-1 | Zydus LifesciencesIndia | 26 December 2017 |
| 1000 tablet, film coated in 1 bottle | 70771-1175-0 | Zydus LifesciencesIndia | 26 December 2017 |
| 100 tablet, film coated in 1 bottle | 70771-1175-1 | Zydus LifesciencesIndia | 26 December 2017 |
| 100 tablet, film coated in 1 bottle | 59651-819-01 | Aurobindo PharmaIndia | 20 March 2026 |
| 1000 tablet, film coated in 1 bottle | 59651-819-99 | Aurobindo PharmaIndia | 20 March 2026 |
| 100 tablet in 1 bottle | 64330-632-01 | Centaur PharmaceuticalsIndia | 6 June 2022 |
| 100 tablet, film coated in 1 bottle | 70756-203-11 | Lifestar PharmaIndia | 23 February 2021 |
| 1000 tablet, film coated in 1 bottle | 70756-203-12 | Lifestar PharmaIndia | 23 February 2021 |
| 1000 tablet, film coated in 1 bottle, plastic | 57664-689-18 | Sun Pharmaceutical IndustriesIndia | 14 July 1987 |
| 100 tablet, film coated in 1 bottle, plastic | 57664-689-88 | Sun Pharmaceutical IndustriesIndia | 14 July 1987 |
| 100 tablet, film coated in 1 bottle | 29300-421-01 | Unichem LaboratoriesIndia | 26 May 2021 |
| 500 tablet, film coated in 1 bottle | 29300-421-05 | Unichem LaboratoriesIndia | 26 May 2021 |
| 1000 tablet, film coated in 1 bottle | 29300-421-10 | Unichem LaboratoriesIndia | 16 November 2021 |
| 1000 tablet, film coated in 1 bottle | 72888-069-00 | Advagen Pharma | 1 May 2023 |
| 100 tablet, film coated in 1 bottle | 72888-069-01 | Advagen Pharma | 1 May 2023 |
| 100 tablet in 1 bottle | 11788-079-01 | AiPing Pharmaceutical | 1 November 2025 |
| 1000 tablet in 1 bottle | 11788-079-10 | AiPing Pharmaceutical | 1 November 2025 |
| 100 tablet in 1 bottle | 16571-107-01 | Rising Pharma Holdings | 10 June 2023 |
| 1000 tablet in 1 bottle | 16571-107-10 | Rising Pharma Holdings | 10 June 2023 |
| 100 tablet, film coated in 1 bottle | 0781-1488-01 | Sandoz | 29 November 1977 |
| 1000 tablet, film coated in 1 bottle | 0781-1488-10 | Sandoz | 29 November 1977 |
| 100 tablet, film coated in 1 bottle | 50090-6315-0 | A-S Medication Solutions | 6 January 2023 |
| 30 tablet, film coated in 1 bottle | 50090-6315-1 | A-S Medication Solutions | 6 January 2023 |
| 60 tablet, film coated in 1 bottle | 50090-6315-2 | A-S Medication Solutions | 6 January 2023 |
| 90 tablet, film coated in 1 bottle | 50090-6315-5 | A-S Medication Solutions | 6 January 2023 |
| 100 tablet, film coated in 1 bottle | 50090-7183-0 | A-S Medication Solutions | 18 June 2024 |
| 30 tablet, film coated in 1 bottle | 50090-7183-1 | A-S Medication Solutions | 18 June 2024 |
| 60 tablet, film coated in 1 bottle | 50090-7183-2 | A-S Medication Solutions | 18 June 2024 |
| 90 tablet, film coated in 1 bottle | 50090-7183-5 | A-S Medication Solutions | 18 June 2024 |
| 100 tablet in 1 bottle | 50090-7598-0 | A-S Medication Solutions | 7 July 2025 |
| 30 tablet in 1 bottle | 50090-7598-1 | A-S Medication Solutions | 7 July 2025 |
| 60 tablet in 1 bottle | 50090-7598-2 | A-S Medication Solutions | 7 July 2025 |
| 90 tablet in 1 bottle | 50090-7598-5 | A-S Medication Solutions | 7 July 2025 |
| 100 tablet, coated in 1 bottle | 50090-7599-0 | A-S Medication Solutions | 9 July 2025 |
| 30 tablet, coated in 1 bottle | 50090-7599-1 | A-S Medication Solutions | 9 July 2025 |
| 60 tablet, coated in 1 bottle | 50090-7599-2 | A-S Medication Solutions | 9 July 2025 |
| 90 tablet, coated in 1 bottle | 50090-7599-5 | A-S Medication Solutions | 9 July 2025 |
| 100 tablet in 1 bottle | 50090-8135-0 | A-S Medication Solutions | 8 October 2026 |
| 30 tablet in 1 bottle | 50090-8135-1 | A-S Medication Solutions | 8 October 2026 |
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 7 April 1961 | 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 Amitriptyline
Clinical summary
Amitriptyline is a tricyclic antidepressant. It is available as tablets for oral use. MedsAcross supplies Amitriptyline 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 AmitriptylineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Amitriptyline Hydrochloride prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Amitriptyline 50 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.