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Medicine

Provigil 100 mg tablet

Modafinil · Oral · Apotex
Available on requestPrescription onlyUS FDAControlled, schedule CIV

Provigil 100 mg tablet is a prescription medicine containing Modafinil for oral use, marketed by Apotex, 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-25 • C (68 • F-77 • F).

Key facts

Active ingredient (INN)
Modafinil
Brand
Provigil
Strength
100 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets
Marketing authorisation holder
Apotex
Manufacturers
ApotexGolden State Medical Supply
Origin register
US FDA, United States
Storage
Store at 20 • C-25 • C (68 • F-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
24 December 1998
Identifiers
RxCUI 205324, 213471, 226426 +1DailyMed set ID 3b8d1c32-dac9-50e6-e063-6394a90aa5a5, 0391f182-1958-9fef-a944-53b229ce99e7NDC 60429-009, 60505-4851Application NDA020717

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

PackCodeLabelerMarketed since
30 tablet in 1 bottle60505-4851-3Apotex31 August 2025
30 tablet in 1 bottle60429-009-30Golden State Medical Supply8 July 2025

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 100 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 Provigil 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.