FDA Orange Book
Generic for Lamictal ODT
Lamictal ODT 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 ODT is lamotrigine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Lamictal ODT and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lamictal ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 100MG | Marketed (Rx) | AB | 8 | AB |
| tablet, orally disintegrating, oral | 200MG | Marketed (Rx) | AB | 8 | AB |
| tablet, orally disintegrating, oral | 25MG | Marketed (Rx) | AB | 8 | AB |
| tablet, orally disintegrating, oral | 50MG | Marketed (Rx) | AB | 8 | AB |
NDA 022251, 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 |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 200828 | AB (A-rated, therapeutically equivalent) | July 15, 2013 | 100MG, 200MG, 25MG, 50MG |
| PH HEALTH LTD | 204158 | AB (A-rated, therapeutically equivalent) | October 27, 2015 | 100MG, 200MG, 25MG, 50MG |
| SCIEGEN PHARMACEUTICALS INC | 206382 | AB (A-rated, therapeutically equivalent) | June 17, 2016 | 100MG, 200MG, 25MG, 50MG |
| AJANTA PHARMA LTD | 213271 | AB (A-rated, therapeutically equivalent) | January 19, 2021 | 100MG, 200MG, 25MG, 50MG |
| J MOLNER HOLDINGS INC | 214124 | AB (A-rated, therapeutically equivalent) | February 3, 2022 | 100MG, 200MG, 25MG, 50MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 219677 | AB (A-rated, therapeutically equivalent) | October 7, 2025 | 100MG, 200MG, 25MG, 50MG |
| TORRENT PHARMACEUTICALS LTD | 217100 | AB (A-rated, therapeutically equivalent) | January 8, 2026 | 100MG, 200MG, 25MG, 50MG |
| ALEMBIC PHARMACEUTICALS LTD | 217278 | AB (A-rated, therapeutically equivalent) | February 25, 2026 | 100MG, 200MG, 25MG, 50MG |
Lamictal ODT NDC codes
Questions
Is there a generic for Lamictal ODT?
Yes. The generic name for Lamictal ODT is lamotrigine. 8 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 ODT?
The active ingredient in Lamictal ODT 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.