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Active ingredient

Modafinil

57 finished FDA listings contain Modafinil as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MODAFINIL
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
22
Strengths listed
100 mg/1 · 200 mg/1
Brand names in FDA listings
Provigil

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 30125

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020717NUVO PHARMS1998-12-249
ANDA 078963ORBION PHARMS2012-09-264
ANDA 202566AUROBINDO PHARMA LTD2012-09-2716
ANDA 202700ALEMBIC2012-10-184
ANDA 077667APOTEX2014-02-036
ANDA 207196APPCO2017-08-166
ANDA 209966CADILA2017-09-1412

Official labeling on DailyMed

Showing the 12 most recent of 35 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.