FDA Orange Book
Generic for Biaxin XL
Biaxin XL contains clarithromycin. 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 Biaxin XL is clarithromycin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Biaxin XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 500MG | Discontinued | None | 4 | AB |
NDA 050775, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clarithromycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 065145 | AB (A-rated, therapeutically equivalent) | June 24, 2004 | 500MG |
| DR REDDYS LABORATORIES SA | 065154 | AB (A-rated, therapeutically equivalent) | May 18, 2005 | 500MG |
| MPP PHARMA LLC | 203243 | AB (A-rated, therapeutically equivalent) | February 29, 2016 | 500MG |
| SUNSHINE LAKE PHARMA CO LTD | 208987 | AB (A-rated, therapeutically equivalent) | July 9, 2018 | 500MG |
Questions
Is there a generic for Biaxin XL?
Yes. The generic name for Biaxin XL is clarithromycin. 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 Biaxin XL?
The active ingredient in Biaxin XL is clarithromycin, 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.