FDA Orange Book
Generic for Lopid
Lopid contains gemfibrozil. 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 Lopid is gemfibrozil. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Lopid products the Orange Book lists.
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Lopid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Discontinued | None | 0 | None |
| capsule, oral | 300MG | Discontinued | None | 0 | None |
| tablet, oral | 600MG | Marketed (Rx) | AB | 8 | AB |
NDA 018422, held by PFIZER PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic gemfibrozil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL MOLECULES LLC | 074270 | AB (A-rated, therapeutically equivalent) | September 27, 1993 | 600MG |
| INVAGEN PHARMACEUTICALS INC | 077836 | AB (A-rated, therapeutically equivalent) | July 27, 2006 | 600MG |
| EPIC PHARMA LLC | 078012 | AB (A-rated, therapeutically equivalent) | March 26, 2007 | 600MG |
| IMPAX PHARMACEUTICALS | 078207 | AB (A-rated, therapeutically equivalent) | June 1, 2007 | 600MG |
| NORTHSTAR HEALTHCARE HOLDINGS LTD | 079072 | AB (A-rated, therapeutically equivalent) | September 13, 2010 | 600MG |
| AUROBINDO PHARMA LTD | 202726 | AB (A-rated, therapeutically equivalent) | September 16, 2015 | 600MG |
| CADILA PHARMACEUTICALS LTD | 203266 | AB (A-rated, therapeutically equivalent) | June 17, 2016 | 600MG |
| ASCENT PHARMACEUTICALS INC | 214603 | AB (A-rated, therapeutically equivalent) | January 13, 2021 | 600MG |
Lopid NDC codes
Questions
Is there a generic for Lopid?
Yes. The generic name for Lopid is gemfibrozil. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Lopid products the Orange Book lists.
What is the generic name for Lopid?
The active ingredient in Lopid is gemfibrozil, 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.