FDA Orange Book

Generic for Lamictal

Lamictal contains lamotrigine. 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 Lamictal is lamotrigine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Lamictal products in the Orange Book

Lamictal products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	100MG	Marketed (Rx)	AB	12	AB
tablet, oral	150MG	Marketed (Rx)	AB	12	AB
tablet, oral	200MG	Marketed (Rx)	AB	12	AB
tablet, oral	250MG	Discontinued	None	1	None
tablet, oral	25MG	Marketed (Rx)	AB	12	AB
tablet, oral	50MG	Discontinued	None	1	None

NDA 020241, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic lamotrigine

Approved generic versions of Lamictal
Company	ANDA	TE code	Approved	Strengths
AUROBINDO PHARMA LTD	078956	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 25MG
DR REDDYS LABORATORIES LTD	076708	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 25MG
JUBILANT CADISTA PHARMACEUTICALS INC	079132	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 25MG
RUBICON RESEARCH LTD	078625	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 25MG
TARO PHARMACEUTICAL INDUSTRIES LTD	078525	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 25MG
TORRENT PHARMACEUTICALS LTD	078947	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 25MG
ZYDUS PHARMACEUTICALS USA INC	077633	AB (A-rated, therapeutically equivalent)	January 27, 2009	100MG, 150MG, 200MG, 250MG, 25MG, 50MG
ALEMBIC PHARMACEUTICALS LTD	090607	AB (A-rated, therapeutically equivalent)	January 13, 2011	100MG, 150MG, 200MG, 25MG
UNICHEM LABORATORIES LTD	090170	AB (A-rated, therapeutically equivalent)	October 6, 2011	100MG, 150MG, 200MG, 25MG
GLENMARK PHARMACEUTICALS LTD	090169	AB (A-rated, therapeutically equivalent)	May 4, 2012	100MG, 150MG, 200MG, 25MG
ALKEM LABORATORIES LTD	200694	AB (A-rated, therapeutically equivalent)	June 14, 2013	100MG, 150MG, 200MG, 25MG
IPCA LABORATORIES LTD	204499	AB (A-rated, therapeutically equivalent)	September 26, 2024	100MG, 150MG, 200MG, 25MG

Lamictal NDC codes

Questions

Is there a generic for Lamictal?

Yes. The generic name for Lamictal is lamotrigine. 12 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 Lamictal?

The active ingredient in Lamictal is lamotrigine, 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.