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Medicine

Sertraline 100 mg tablet

Sertraline · Oral
Available on requestPrescription onlyUS FDAGeneric name

Sertraline 100 mg tablet is a generic prescription medicine for oral use, made by 34 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…

Key facts

Active ingredient (INN)
Sertraline
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 2500 tablets and 225 more
Manufacturers
Aurobindo PharmaIndiaLupinIndiaCiplaIndiaGranules IndiaIndiaAvet PharmaceuticalsIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndia34 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F 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 312938, 312940, 312941DailyMed set ID 03e1f274-fa9a-4461-b7c9-31ba6428c107, 30b94d67-0000-a045-e063-6394a90ade32, c4bad433-623b-402c-b454-d39f19a23627 +37NDC 71335-3115, 71610-886, 72789-092 +37Application ANDA076465, ANDA077397, ANDA077206 +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 34 labelers. The register lists 228 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle65862-013-01Aurobindo PharmaIndia6 February 2007
500 tablet, film coated in 1 bottle65862-013-05Aurobindo PharmaIndia6 February 2007
2500 tablet, film coated in 1 bottle65862-013-25Aurobindo PharmaIndia6 February 2007
30 tablet, film coated in 1 bottle65862-013-30Aurobindo PharmaIndia6 February 2007
50 tablet, film coated in 1 bottle65862-013-50Aurobindo PharmaIndia6 February 2007
60 tablet, film coated in 1 bottle65862-013-60Aurobindo PharmaIndia6 February 2007
90 tablet, film coated in 1 bottle65862-013-90Aurobindo PharmaIndia6 February 2007
1000 tablet, film coated in 1 bottle65862-013-99Aurobindo PharmaIndia6 February 2007
100 tablet, film coated in 1 bottle84386-099-01Aurobindo PharmaIndia20 November 2025
500 tablet, film coated in 1 bottle84386-099-05Aurobindo PharmaIndia20 November 2025
2500 tablet, film coated in 1 bottle84386-099-25Aurobindo PharmaIndia20 November 2025
30 tablet, film coated in 1 bottle84386-099-30Aurobindo PharmaIndia20 November 2025
50 tablet, film coated in 1 bottle84386-099-50Aurobindo PharmaIndia20 November 2025
60 tablet, film coated in 1 bottle84386-099-60Aurobindo PharmaIndia20 November 2025
90 tablet, film coated in 1 bottle84386-099-90Aurobindo PharmaIndia20 November 2025
1000 tablet, film coated in 1 bottle84386-099-99Aurobindo PharmaIndia20 November 2025
500 tablet, film coated in 1 bottle68180-353-02LupinIndia6 February 2007
5000 tablet, film coated in 1 bottle68180-353-05LupinIndia6 February 2007
30 tablet, film coated in 1 bottle68180-353-06LupinIndia6 February 2007
90 tablet, film coated in 1 bottle68180-353-09LupinIndia6 February 2007
30 tablet, film coated in 1 bottle68180-992-01LupinIndia6 August 2025
90 tablet, film coated in 1 bottle68180-992-02LupinIndia6 August 2025
500 tablet, film coated in 1 bottle68180-992-03LupinIndia6 August 2025
5000 tablet, film coated in 1 bottle68180-992-04LupinIndia6 August 2025
90 tablet, film coated in 1 bottle16729-217-15Accord HealthcareIndia10 March 2017
500 tablet, film coated in 1 bottle16729-217-16Accord HealthcareIndia9 February 2017
30 tablet, film coated in 1 bottle23155-759-03Avet PharmaceuticalsIndia23 February 2023
500 tablet, film coated in 1 bottle23155-759-05Avet PharmaceuticalsIndia23 March 2023
90 tablet, film coated in 1 bottle23155-759-09Avet PharmaceuticalsIndia23 February 2023
500 tablet in 1 bottle31722-147-05Camber PharmaceuticalsIndia3 May 2021
30 tablet in 1 bottle31722-147-30Camber PharmaceuticalsIndia3 May 2021
90 tablet in 1 bottle31722-147-90Camber PharmaceuticalsIndia3 May 2021
30 tablet in 1 bottle69097-835-02CiplaIndia21 July 2016
90 tablet in 1 bottle69097-835-05CiplaIndia21 July 2016
100 tablet in 1 bottle69097-835-07CiplaIndia21 July 2016
500 tablet in 1 bottle69097-835-12CiplaIndia21 July 2016
100 tablet, film coated in 1 bottle70010-205-01Granules IndiaIndia15 May 2023
30 tablet, film coated in 1 bottle70010-205-03Granules IndiaIndia15 May 2023
500 tablet, film coated in 1 bottle70010-205-05Granules IndiaIndia15 May 2023
90 tablet, film coated in 1 bottle70010-205-09Granules IndiaIndia15 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 December 1991Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 100 mg tablet.

Compare 1

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 Sertraline

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Sertraline 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.