Medicine
Modafinil 100 mg tablet
Modafinil 100 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20o to 25C (68 to 77F).
Key facts
- Active ingredient (INN)
- Modafinil
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 60 tablets and 57 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaAsclemedBionpharmaRising Pharma HoldingsApotexCima Labs18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20o to 25C (68 to 77F).
- 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 260218, 205324DailyMed set ID f1ff7c6d-df04-48dd-a971-454d38e7d997, 463bb960-a0b5-4ca4-e063-6294a90a683b, 15739a31-2433-49b5-90ea-b974214f73be +18NDC 71335-1122, 71610-976, 72578-005 +18Application ANDA202566, ANDA209966, NDA020717 +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 60 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 carton | 46708-385-10 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 30 tablet in 1 bottle | 46708-385-30 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 60 tablet in 1 bottle | 46708-385-60 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 90 tablet in 1 bottle | 46708-385-90 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 1000 tablet in 1 bottle | 46708-385-91 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 100 tablet in 1 carton | 62332-385-10 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 30 tablet in 1 bottle | 62332-385-30 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 60 tablet in 1 bottle | 62332-385-60 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 90 tablet in 1 bottle | 62332-385-90 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 1000 tablet in 1 bottle | 62332-385-91 | Alembic PharmaceuticalsIndia | 30 June 2017 |
| 100 tablet in 1 bottle | 65862-601-01 | Aurobindo PharmaIndia | 27 September 2012 |
| 30 tablet in 1 bottle | 65862-601-30 | Aurobindo PharmaIndia | 27 September 2012 |
| 90 tablet in 1 bottle | 65862-601-90 | Aurobindo PharmaIndia | 27 September 2012 |
| 1000 tablet in 1 bottle | 65862-601-99 | Aurobindo PharmaIndia | 27 September 2012 |
| 100 tablet in 1 bottle, plastic | 23155-604-01 | Avet PharmaceuticalsIndia | 18 February 2021 |
| 30 tablet in 1 bottle, plastic | 23155-604-03 | Avet PharmaceuticalsIndia | 18 February 2021 |
| 500 tablet in 1 bottle, plastic | 23155-604-05 | Avet PharmaceuticalsIndia | 18 February 2021 |
| 90 tablet in 1 bottle, plastic | 23155-604-09 | Avet PharmaceuticalsIndia | 18 February 2021 |
| 100 tablet in 1 bottle | 72578-005-01 | Viona PharmaceuticalsIndia | 15 February 2019 |
| 30 tablet in 1 bottle | 72578-005-06 | Viona PharmaceuticalsIndia | 15 February 2019 |
| 90 tablet in 1 bottle | 72578-005-16 | Viona PharmaceuticalsIndia | 15 February 2019 |
| 100 tablet in 1 bottle | 70771-1051-1 | Zydus LifesciencesIndia | 4 January 2018 |
| 30 tablet in 1 bottle | 70771-1051-3 | Zydus LifesciencesIndia | 4 January 2018 |
| 90 tablet in 1 bottle | 70771-1051-9 | Zydus LifesciencesIndia | 4 January 2018 |
| 100 tablet in 1 bottle | 60505-2526-1 | Apotex | 14 January 2021 |
| 30 tablet in 1 bottle | 60505-2526-3 | Apotex | 3 February 2014 |
| 30 tablet in 1 bottle, plastic | 69452-342-13 | Bionpharma | 28 February 2022 |
| 90 tablet in 1 bottle, plastic | 69452-342-19 | Bionpharma | 28 February 2022 |
| 100 tablet in 1 bottle, plastic | 69452-342-20 | Bionpharma | 28 February 2022 |
| 30 tablet in 1 bottle | 55253-801-30 | Cima Labs | 29 March 2012 |
| 100 tablet in 1 bottle | 57237-154-01 | Rising Pharma Holdings | 27 September 2012 |
| 30 tablet in 1 bottle | 57237-154-30 | Rising Pharma Holdings | 27 September 2012 |
| 90 tablet in 1 bottle | 57237-154-90 | Rising Pharma Holdings | 27 September 2012 |
| 100 tablet in 1 bottle | 87063-306-01 | Asclemed | 10 September 2026 |
| 30 tablet in 1 bottle | 87063-306-30 | Asclemed | 10 September 2026 |
| 60 tablet in 1 bottle | 87063-306-60 | Asclemed | 10 September 2026 |
| 90 tablet in 1 bottle | 87063-306-90 | Asclemed | 10 September 2026 |
| 100 tablet in 1 bottle | 87063-308-01 | Asclemed | 10 September 2026 |
| 30 tablet in 1 bottle | 87063-308-30 | Asclemed | 10 September 2026 |
| 60 tablet in 1 bottle | 87063-308-60 | Asclemed | 10 September 2026 |
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 24 December 1998 | 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 Modafinil 100 mg tablet.
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 ModafinilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Provigil prescribing information (Apotex) · U.S. National Library of Medicine, DailyMed
Need Modafinil 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.