FDA Orange Book
Generic for Prevpac (copackaged)
Prevpac (copackaged) contains amoxicillin, clarithromycin and lansoprazole. 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 Prevpac (copackaged) is amoxicillin, clarithromycin and lansoprazole. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Prevpac (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, tablet, capsule, delayed rel pellets, oral | 500MG;500MG;30MG | Discontinued | None | 2 | AB |
NDA 050757, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amoxicillin, clarithromycin and lansoprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 202588 | AB (A-rated, therapeutically equivalent) | March 4, 2014 | 500MG;500MG;30MG |
| RISING PHARMA HOLDINGS INC | 206006 | AB (A-rated, therapeutically equivalent) | October 7, 2016 | 500MG;500MG;30MG |
Questions
Is there a generic for Prevpac (copackaged)?
Yes. The generic name for Prevpac (copackaged) is amoxicillin, clarithromycin and lansoprazole. 2 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 Prevpac (copackaged)?
The active ingredient in Prevpac (copackaged) is amoxicillin, clarithromycin and lansoprazole, 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.