FDA Orange Book
Generic for Eskalith
Eskalith contains lithium carbonate. 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 Eskalith is lithium carbonate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Eskalith products the Orange Book lists.
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Eskalith products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 300MG | Discontinued | None | 3 | AB |
| tablet, oral | 300MG | Discontinued | None | 0 | None |
NDA 016860, 017971, held by NOVEN THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lithium carbonate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC LTD | 079159 | AB (A-rated, therapeutically equivalent) | January 12, 2009 | 300MG |
| GLENMARK PHARMACEUTICALS LTD | 079139 | AB (A-rated, therapeutically equivalent) | February 3, 2009 | 300MG |
| HETERO LABS LTD UNIT III | 090702 | AB (A-rated, therapeutically equivalent) | September 25, 2009 | 300MG |
Questions
Is there a generic for Eskalith?
Yes. The generic name for Eskalith is lithium carbonate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Eskalith products the Orange Book lists.
What is the generic name for Eskalith?
The active ingredient in Eskalith is lithium carbonate, 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.