Medicine
Amitriptyline 100 mg tablet
Amitriptyline 100 mg tablet is a generic prescription medicine for oral use, made by 25 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 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Amitriptyline
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 100 tablets, 60 tablets and 61 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaCentaur PharmaceuticalsIndiaLifestar PharmaIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackA-S Medication SolutionsPreferred PharmaceuticalsAdvagen Pharma25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°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
- 21 November 1977
- Identifiers
- RxCUI 856762, 856773, 856783 +3DailyMed set ID 1b2d2bb8-78c8-7e8e-e063-6294a90a2576, 50375dab-97fe-8c84-e063-6394a90a60b2, bb02d7b8-8f1a-4cc4-b763-223e6894f02c +29NDC 60760-907, 67046-0764, 70518-4054 +30Application ANDA214548, ANDA217411, ANDA210086 +8
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 25 labelers. The register lists 64 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 | 70710-1229-0 | Zydus LifesciencesIndia | 26 December 2017 |
| 100 tablet, film coated in 1 bottle | 70710-1229-1 | Zydus LifesciencesIndia | 26 December 2017 |
| 1000 tablet, film coated in 1 bottle | 70771-1177-0 | Zydus LifesciencesIndia | 26 December 2017 |
| 100 tablet, film coated in 1 bottle | 70771-1177-1 | Zydus LifesciencesIndia | 26 December 2017 |
| 100 tablet, film coated in 1 bottle | 59651-821-01 | Aurobindo PharmaIndia | 20 March 2026 |
| 60 tablet, film coated in 1 bottle | 59651-821-60 | Aurobindo PharmaIndia | 20 March 2026 |
| 100 tablet in 1 bottle | 64330-634-01 | Centaur PharmaceuticalsIndia | 6 June 2022 |
| 100 tablet, film coated in 1 bottle | 70756-205-11 | Lifestar PharmaIndia | 23 February 2021 |
| 100 tablet, film coated in 1 bottle, plastic | 57664-690-88 | Sun Pharmaceutical IndustriesIndia | 14 July 1987 |
| 100 tablet, film coated in 1 bottle | 29300-423-01 | Unichem LaboratoriesIndia | 26 May 2021 |
| 500 tablet, film coated in 1 bottle | 29300-423-05 | Unichem LaboratoriesIndia | 26 May 2021 |
| 100 tablet, film coated in 1 bottle | 72888-071-01 | Advagen Pharma | 1 May 2023 |
| 300 tablet, film coated in 1 bottle | 72888-071-03 | Advagen Pharma | 1 May 2023 |
| 100 tablet in 1 bottle | 11788-081-01 | AiPing Pharmaceutical | 1 November 2025 |
| 100 tablet in 1 bottle | 16571-109-01 | Rising Pharma Holdings | 10 June 2023 |
| 100 tablet, film coated in 1 bottle | 0781-1490-01 | Sandoz | 21 November 1977 |
| 60 tablet, film coated in 1 bottle | 50090-3564-2 | A-S Medication Solutions | 30 August 2018 |
| 60 tablet, film coated in 1 bottle | 50090-6418-2 | A-S Medication Solutions | 31 March 2023 |
| 60 tablet in 1 bottle | 50090-7583-2 | A-S Medication Solutions | 19 June 2025 |
| 30 tablet in 1 bottle | 71335-2374-1 | Bryant Ranch Prepack | 29 May 2024 |
| 60 tablet in 1 bottle | 71335-2374-2 | Bryant Ranch Prepack | 29 May 2024 |
| 90 tablet in 1 bottle | 71335-2374-3 | Bryant Ranch Prepack | 29 May 2024 |
| 180 tablet in 1 bottle | 71335-2374-4 | Bryant Ranch Prepack | 29 May 2024 |
| 28 tablet in 1 bottle | 71335-2374-5 | Bryant Ranch Prepack | 29 May 2024 |
| 120 tablet in 1 bottle | 71335-2374-6 | Bryant Ranch Prepack | 29 May 2024 |
| 18 tablet in 1 bottle | 71335-2374-7 | Bryant Ranch Prepack | 29 May 2024 |
| 8 tablet in 1 bottle | 71335-2374-8 | Bryant Ranch Prepack | 29 May 2024 |
| 30 tablet, film coated in 1 bottle | 71335-9668-1 | Bryant Ranch Prepack | 27 March 2023 |
| 60 tablet, film coated in 1 bottle | 71335-9668-2 | Bryant Ranch Prepack | 27 March 2023 |
| 90 tablet, film coated in 1 bottle | 71335-9668-3 | Bryant Ranch Prepack | 27 March 2023 |
| 180 tablet, film coated in 1 bottle | 71335-9668-4 | Bryant Ranch Prepack | 27 March 2023 |
| 28 tablet, film coated in 1 bottle | 71335-9668-5 | Bryant Ranch Prepack | 27 March 2023 |
| 120 tablet, film coated in 1 bottle | 71335-9668-6 | Bryant Ranch Prepack | 27 March 2023 |
| 18 tablet, film coated in 1 bottle | 71335-9668-7 | Bryant Ranch Prepack | 27 March 2023 |
| 8 tablet, film coated in 1 bottle | 71335-9668-8 | Bryant Ranch Prepack | 27 March 2023 |
| 30 tablet, film coated in 1 blister pack | 67046-0764-3 | Coupler | 24 April 2026 |
| 30 tablet, film coated in 1 blister pack | 67046-1694-3 | Coupler | 21 August 2026 |
| 30 tablet in 1 bottle | 68788-4052-3 | Preferred Pharmaceuticals | 17 November 2025 |
| 60 tablet in 1 bottle | 68788-4052-6 | Preferred Pharmaceuticals | 17 November 2025 |
| 28 tablet in 1 bottle | 68788-4052-8 | Preferred Pharmaceuticals | 17 November 2025 |
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 100 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.