FDA Orange Book

Generic for Nuvigil

Nuvigil contains armodafinil. 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 Nuvigil is armodafinil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Nuvigil products in the Orange Book

Nuvigil products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	100MG	Discontinued	None	2	AB
tablet, oral	150MG	Marketed (Rx)	AB	4	AB
tablet, oral	200MG	Marketed (Rx)	AB	3	AB
tablet, oral	250MG	Marketed (Rx)	AB	4	AB
tablet, oral	50MG	Marketed (Rx)	AB	4	AB

NDA 021875, 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 armodafinil

Approved generic versions of Nuvigil
Company	ANDA	TE code	Approved	Strengths
NATCO PHARMA LTD	202768	AB (A-rated, therapeutically equivalent)	September 28, 2017	100MG, 150MG, 200MG, 250MG, 50MG
AUROBINDO PHARMA LTD	206069	AB (A-rated, therapeutically equivalent)	March 6, 2018	150MG, 200MG, 250MG, 50MG
MACLEODS PHARMACEUTICALS LTD	201514	AB (A-rated, therapeutically equivalent)	March 25, 2019	150MG, 250MG, 50MG
MYLAN PHARMACEUTICALS INC	200043	AB (A-rated, therapeutically equivalent)	May 9, 2019	100MG, 150MG, 200MG, 250MG, 50MG

Nuvigil NDC codes

Questions

Is there a generic for Nuvigil?

Yes. The generic name for Nuvigil is armodafinil. 4 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 Nuvigil?

The active ingredient in Nuvigil is armodafinil, 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.