FDA Orange Book
Generic for Lithonate
Lithonate contains lithium citrate. 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 Lithonate is lithium citrate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Lithonate 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 |
| syrup, oral | EQ 300MG CARBONATE/5ML | Discontinued | None | 3 | AA |
NDA 016782, 017672, held by SOLVAY PHARMACEUTICALS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lithium citrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC | 070755 | AA (A-rated, therapeutically equivalent) | May 21, 1986 | EQ 300MG CARBONATE/5ML |
| 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 |
| RUBICON RESEARCH LTD | 218036 | AA (A-rated, therapeutically equivalent) | August 14, 2023 | EQ 300MG CARBONATE/5ML |
| SCIEGEN PHARMACEUTICALS INC | 217183 | AA (A-rated, therapeutically equivalent) | March 18, 2024 | EQ 300MG CARBONATE/5ML |
Questions
Is there a generic for Lithonate?
Yes. The generic name for Lithonate is lithium citrate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Lithonate?
The active ingredient in Lithonate is lithium citrate, 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.