FDA Orange Book

Generic for Provigil

Provigil contains modafinil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Provigil is modafinil. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Provigil products in the Orange Book

Provigil products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	100MG	Marketed (Rx)	AB	7	AB
tablet, oral	200MG	Marketed (Rx)	AB	7	AB

NDA 020717, held by NUVO PHARMACEUTICALS (IRELAND) DAC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic modafinil

Approved generic versions of Provigil
Company	ANDA	TE code	Approved	Strengths
ORBION PHARMACEUTICALS PRIVATE LTD	078963	AB (A-rated, therapeutically equivalent)	September 26, 2012	100MG, 200MG
AUROBINDO PHARMA LTD	202566	AB (A-rated, therapeutically equivalent)	September 27, 2012	100MG, 200MG
ALEMBIC PHARMACEUTICALS LTD	202700	AB (A-rated, therapeutically equivalent)	October 18, 2012	100MG, 200MG
APOTEX INC	077667	AB (A-rated, therapeutically equivalent)	February 3, 2014	100MG, 200MG
APPCO PHARMA LLC	207196	AB (A-rated, therapeutically equivalent)	August 16, 2017	100MG, 200MG
CADILA HEALTHCARE LTD	209966	AB (A-rated, therapeutically equivalent)	September 14, 2017	100MG, 200MG
LUPIN LTD	208343	AB (A-rated, therapeutically equivalent)	September 3, 2026	100MG, 200MG

Provigil NDC codes

Questions

Is there a generic for Provigil?

Yes. The generic name for Provigil is modafinil. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Provigil?

The active ingredient in Provigil is modafinil, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.