Medicine
Sertraline 50 mg tablet
Sertraline 50 mg tablet is a generic prescription medicine for oral use, made by 35 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 15º to 30ºC (59°…
Key facts
- Active ingredient (INN)
- Sertraline
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 203 more
- Manufacturers
- Aurobindo PharmaIndiaLupinIndiaAvet PharmaceuticalsIndiaCiplaIndiaCamber PharmaceuticalsIndiaGranules IndiaIndiaAccord HealthcareIndia35 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15º to 30ºC (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AB06 Sertraline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 February 2007
- Identifiers
- RxCUI 312941, 312938, 312940DailyMed set ID 4ddfd698-3d47-fc0e-e063-6394a90accec, 286b429d-62b9-4ca8-a243-de3f619315bf, 513ecb5b-062f-455f-b798-1c9a54222ff3 +37NDC 82868-100, 50090-2071, 50090-6379 +37Application ANDA078403, ANDA077206, ANDA077397 +5
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 35 labelers. The register lists 206 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-012-01 | Aurobindo PharmaIndia | 6 February 2007 |
| 500 tablet, film coated in 1 bottle | 65862-012-05 | Aurobindo PharmaIndia | 6 February 2007 |
| 30 tablet, film coated in 1 bottle | 65862-012-30 | Aurobindo PharmaIndia | 6 February 2007 |
| 50 tablet, film coated in 1 bottle | 65862-012-50 | Aurobindo PharmaIndia | 6 February 2007 |
| 5000 tablet, film coated in 1 bottle | 65862-012-51 | Aurobindo PharmaIndia | 6 February 2007 |
| 60 tablet, film coated in 1 bottle | 65862-012-60 | Aurobindo PharmaIndia | 6 February 2007 |
| 90 tablet, film coated in 1 bottle | 65862-012-90 | Aurobindo PharmaIndia | 6 February 2007 |
| 1000 tablet, film coated in 1 bottle | 65862-012-99 | Aurobindo PharmaIndia | 6 February 2007 |
| 100 tablet, film coated in 1 bottle | 84386-098-01 | Aurobindo PharmaIndia | 20 November 2025 |
| 500 tablet, film coated in 1 bottle | 84386-098-05 | Aurobindo PharmaIndia | 20 November 2025 |
| 30 tablet, film coated in 1 bottle | 84386-098-30 | Aurobindo PharmaIndia | 20 November 2025 |
| 50 tablet, film coated in 1 bottle | 84386-098-50 | Aurobindo PharmaIndia | 20 November 2025 |
| 5000 tablet, film coated in 1 bottle | 84386-098-51 | Aurobindo PharmaIndia | 20 November 2025 |
| 60 tablet, film coated in 1 bottle | 84386-098-60 | Aurobindo PharmaIndia | 20 November 2025 |
| 90 tablet, film coated in 1 bottle | 84386-098-90 | Aurobindo PharmaIndia | 20 November 2025 |
| 1000 tablet, film coated in 1 bottle | 84386-098-99 | Aurobindo PharmaIndia | 20 November 2025 |
| 500 tablet, film coated in 1 bottle | 68180-352-02 | LupinIndia | 6 February 2007 |
| 5000 tablet, film coated in 1 bottle | 68180-352-05 | LupinIndia | 6 February 2007 |
| 30 tablet, film coated in 1 bottle | 68180-352-06 | LupinIndia | 6 February 2007 |
| 90 tablet, film coated in 1 bottle | 68180-352-09 | LupinIndia | 6 February 2007 |
| 30 tablet, film coated in 1 bottle | 68180-986-01 | LupinIndia | 6 August 2025 |
| 90 tablet, film coated in 1 bottle | 68180-986-02 | LupinIndia | 6 August 2025 |
| 500 tablet, film coated in 1 bottle | 68180-986-03 | LupinIndia | 6 August 2025 |
| 5000 tablet, film coated in 1 bottle | 68180-986-04 | LupinIndia | 6 August 2025 |
| 90 tablet, film coated in 1 bottle | 16729-216-15 | Accord HealthcareIndia | 9 February 2017 |
| 500 tablet, film coated in 1 bottle | 16729-216-16 | Accord HealthcareIndia | 13 February 2017 |
| 30 tablet, film coated in 1 bottle | 23155-758-03 | Avet PharmaceuticalsIndia | 23 February 2023 |
| 500 tablet, film coated in 1 bottle | 23155-758-05 | Avet PharmaceuticalsIndia | 23 February 2023 |
| 90 tablet, film coated in 1 bottle | 23155-758-09 | Avet PharmaceuticalsIndia | 23 February 2023 |
| 5000 tablet, film coated in 1 bottle | 23155-758-69 | Avet PharmaceuticalsIndia | 23 February 2023 |
| 500 tablet in 1 bottle | 31722-146-05 | Camber PharmaceuticalsIndia | 3 May 2021 |
| 30 tablet in 1 bottle | 31722-146-30 | Camber PharmaceuticalsIndia | 3 May 2021 |
| 90 tablet in 1 bottle | 31722-146-90 | Camber PharmaceuticalsIndia | 3 May 2021 |
| 30 tablet in 1 bottle | 69097-834-02 | CiplaIndia | 21 July 2016 |
| 90 tablet in 1 bottle | 69097-834-05 | CiplaIndia | 21 July 2016 |
| 100 tablet in 1 bottle | 69097-834-07 | CiplaIndia | 21 July 2016 |
| 500 tablet in 1 bottle | 69097-834-12 | CiplaIndia | 21 July 2016 |
| 100 tablet, film coated in 1 bottle | 70010-204-01 | Granules IndiaIndia | 15 May 2023 |
| 30 tablet, film coated in 1 bottle | 70010-204-03 | Granules IndiaIndia | 15 May 2023 |
| 500 tablet, film coated in 1 bottle | 70010-204-05 | Granules IndiaIndia | 15 May 2023 |
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 30 December 1991 | 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
Alternatives
Other makers and brands of Sertraline 50 mg tablet.
Other strengths and forms of Sertraline
Clinical summary
Sertraline is a serotonin reuptake inhibitor indicated for the treatment of the following, among other approved uses. It is available as tablets, capsules and oral concentrate. MedsAcross supplies Sertraline 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 SertralineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zoloft prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Sertraline 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.