FDA Orange Book
Generic for Lamictal CD
Lamictal CD 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 CD is lamotrigine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Lamictal CD products the Orange Book lists.
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Lamictal CD products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 100MG | Discontinued | None | 0 | None |
| tablet, for suspension, oral | 25MG | Marketed (Rx) | AB | 6 | AB |
| tablet, for suspension, oral | 2MG | Marketed (Rx) | AB | 1 | AB |
| tablet, for suspension, oral | 5MG | Marketed (Rx) | AB | 6 | AB |
NDA 020764, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 076701 | AB (A-rated, therapeutically equivalent) | January 22, 2009 | 25MG, 5MG |
| WATSON LABORATORIES INC | 076928 | AB (A-rated, therapeutically equivalent) | January 22, 2009 | 25MG, 2MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 078009 | AB (A-rated, therapeutically equivalent) | January 22, 2009 | 25MG, 5MG |
| GLENMARK PHARMACEUTICALS LTD | 079099 | AB (A-rated, therapeutically equivalent) | February 19, 2009 | 25MG, 5MG |
| AUROBINDO PHARMA LTD | 090401 | AB (A-rated, therapeutically equivalent) | November 4, 2009 | 25MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 201168 | AB (A-rated, therapeutically equivalent) | June 12, 2014 | 25MG, 5MG |
Lamictal CD NDC codes
Questions
Is there a generic for Lamictal CD?
Yes. The generic name for Lamictal CD is lamotrigine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Lamictal CD products the Orange Book lists.
What is the generic name for Lamictal CD?
The active ingredient in Lamictal CD 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.