Medicine
Sertraline 20 mg/mL oral concentrate
Sertraline 20 mg/mL oral concentrate is a generic prescription medicine for oral use, made by 3 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
- 20 mg/mL
- Dosage form
- Oral concentrate
- Route
- Oral
- Packs
- 1 bottle and 1 more
- Manufacturers
- Aurobindo PharmaIndiaMylan PharmaceuticalsRising Pharma Holdings
- 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
- 31 October 2008
- Identifiers
- RxCUI 861064DailyMed set ID af2c75a3-131e-4bde-83fd-310fd2c01161, 01800452-c353-4235-a66a-214048752e74, 1a58062b-e635-431a-908d-2651c6a4a21cNDC 64980-409, 65862-224, 59762-0067Application ANDA078861, NDA020990
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 |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 60 mL in 1 bottle, plastic | 65862-224-20 | Aurobindo PharmaIndia | 31 October 2008 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 65862-224-60 | Aurobindo PharmaIndia | 31 October 2008 |
| 1 bottle, dropper in 1 carton / 60 mL in 1 bottle, dropper | 59762-0067-1 | Mylan Pharmaceuticals | 15 May 2018 |
| 1 bottle, plastic in 1 carton / 60 mL in 1 bottle, plastic | 64980-409-06 | Rising Pharma Holdings | 31 October 2008 |
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 20 mg/mL oral concentrate.
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 20 mg/mL oral concentrate 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.