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Medicine

Modafinil 200 mg tablet

Modafinil · Oral
Available on requestPrescription onlyUS FDAControlled, schedule CIVGeneric name

Modafinil 200 mg tablet is a generic prescription medicine for oral use, made by 18 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).

Key facts

Active ingredient (INN)
Modafinil
Brand
Sold under the generic name
Strength
200 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 30 tablets, 60 tablets and 110 more
Manufacturers
Alembic PharmaceuticalsIndiaAvet PharmaceuticalsIndiaAurobindo PharmaIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaAphena Pharma Solutions - TennesseeBionpharmaRising Pharma HoldingsApotexCima Labs18 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77° F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CIV
ATC code
N06BA07 Modafinil
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
29 March 2012
Identifiers
RxCUI 205324, 260218DailyMed set ID e88310cc-f356-4efa-9e61-9db583671904, cad4201c-133c-4a61-9d93-3c5e51695430, 15739a31-2433-49b5-90ea-b974214f73be +26NDC 87063-309, 43353-925, 72578-006 +27Application ANDA209966, NDA020717, ANDA207196 +4

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 18 labelers. The register lists 113 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 carton46708-386-10Alembic PharmaceuticalsIndia30 June 2017
30 tablet in 1 bottle46708-386-30Alembic PharmaceuticalsIndia30 June 2017
60 tablet in 1 bottle46708-386-60Alembic PharmaceuticalsIndia30 June 2017
90 tablet in 1 bottle46708-386-90Alembic PharmaceuticalsIndia30 June 2017
1000 tablet in 1 bottle46708-386-91Alembic PharmaceuticalsIndia30 June 2017
100 tablet in 1 carton62332-386-10Alembic PharmaceuticalsIndia30 June 2017
30 tablet in 1 bottle62332-386-30Alembic PharmaceuticalsIndia30 June 2017
60 tablet in 1 bottle62332-386-60Alembic PharmaceuticalsIndia30 June 2017
90 tablet in 1 bottle62332-386-90Alembic PharmaceuticalsIndia30 June 2017
1000 tablet in 1 bottle62332-386-91Alembic PharmaceuticalsIndia30 June 2017
100 tablet in 1 bottle, plastic23155-605-01Avet PharmaceuticalsIndia18 February 2021
30 tablet in 1 bottle, plastic23155-605-03Avet PharmaceuticalsIndia18 February 2021
500 tablet in 1 bottle, plastic23155-605-05Avet PharmaceuticalsIndia18 February 2021
90 tablet in 1 bottle, plastic23155-605-09Avet PharmaceuticalsIndia18 February 2021
100 tablet in 1 bottle23155-862-01Avet PharmaceuticalsIndia21 February 2024
30 tablet in 1 bottle23155-862-03Avet PharmaceuticalsIndia21 February 2024
500 tablet in 1 bottle23155-862-05Avet PharmaceuticalsIndia21 February 2024
90 tablet in 1 bottle23155-862-09Avet PharmaceuticalsIndia21 February 2024
100 tablet in 1 bottle65862-602-01Aurobindo PharmaIndia27 September 2012
500 tablet in 1 bottle65862-602-05Aurobindo PharmaIndia27 September 2012
30 tablet in 1 bottle65862-602-30Aurobindo PharmaIndia27 September 2012
90 tablet in 1 bottle65862-602-90Aurobindo PharmaIndia27 September 2012
100 tablet in 1 bottle72578-006-01Viona PharmaceuticalsIndia15 February 2019
30 tablet in 1 bottle72578-006-06Viona PharmaceuticalsIndia15 February 2019
90 tablet in 1 bottle72578-006-16Viona PharmaceuticalsIndia15 February 2019
100 tablet in 1 bottle70771-1052-1Zydus LifesciencesIndia4 January 2018
30 tablet in 1 bottle70771-1052-3Zydus LifesciencesIndia4 January 2018
90 tablet in 1 bottle70771-1052-9Zydus LifesciencesIndia4 January 2018
100 tablet in 1 bottle60505-2527-1Apotex14 January 2021
30 tablet in 1 bottle60505-2527-3Apotex3 February 2014
30 tablet in 1 bottle, plastic69452-343-13Bionpharma28 February 2022
90 tablet in 1 bottle, plastic69452-343-19Bionpharma28 February 2022
100 tablet in 1 bottle, plastic69452-343-20Bionpharma28 February 2022
90 tablet in 1 bottle55253-802-90Cima Labs29 March 2012
100 tablet in 1 bottle57237-155-01Rising Pharma Holdings27 September 2012
30 tablet in 1 bottle57237-155-30Rising Pharma Holdings27 September 2012
90 tablet in 1 bottle57237-155-90Rising Pharma Holdings27 September 2012
30 tablet in 1 bottle, plastic43353-925-30Aphena Pharma Solutions - Tennessee17 April 2014
60 tablet in 1 bottle, plastic43353-925-53Aphena Pharma Solutions - Tennessee17 April 2014
30 tablet in 1 bottle71610-685-30Aphena Pharma Solutions - Tennessee11 January 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 24 December 1998Drugs@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 Modafinil 200 mg tablet.

Compare 1

Other strengths and forms of Modafinil

Clinical summary

Modafinil is a sympathomimetic-like agent indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). It is available as tablets for oral use. MedsAcross supplies Modafinil 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 Modafinil

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

Data sources

Need Modafinil 200 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.