FDA Orange Book
Generic for Lithobid
Lithobid 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 Lithobid is lithium carbonate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lithobid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 300MG | Marketed (Rx) | AB | 4 | AB |
NDA 018027, held by ANI PHARMACEUTICALS INC. 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 |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 076832 | AB (A-rated, therapeutically equivalent) | October 28, 2004 | 300MG |
| GLENMARK PHARMACEUTICALS INC USA | 091544 | AB (A-rated, therapeutically equivalent) | December 27, 2010 | 300MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 204779 | AB (A-rated, therapeutically equivalent) | July 27, 2015 | 300MG |
| HERITAGE PHARMA LABS INC | 205532 | AB (A-rated, therapeutically equivalent) | September 29, 2016 | 300MG |
Lithobid NDC codes
Questions
Is there a generic for Lithobid?
Yes. The generic name for Lithobid is lithium carbonate. 4 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 Lithobid?
The active ingredient in Lithobid 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.