FDA Orange Book
Generic for Biaxin
Biaxin 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 is clarithromycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Biaxin products the Orange Book lists.
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Biaxin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 125MG/5ML | Discontinued | None | 1 | None |
| for suspension, oral | 187MG/5ML | Discontinued | None | 0 | None |
| for suspension, oral | 250MG/5ML | Discontinued | None | 1 | None |
| tablet, oral | 250MG | Discontinued | None | 6 | AB |
| tablet, oral | 500MG | Discontinued | None | 6 | AB |
NDA 050698, 050662, 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 |
|---|---|---|---|---|
| SANDOZ INC | 065136 | AB (A-rated, therapeutically equivalent) | August 25, 2005 | 500MG |
| SANDOZ INC | 065144 | AB (A-rated, therapeutically equivalent) | October 18, 2005 | 250MG |
| CHARTWELL LIFE MOLECULES LLC | 065384 | AB (A-rated, therapeutically equivalent) | August 20, 2007 | 250MG, 500MG |
| SANDOZ INC | 065283 | None (No TE code listed) | September 4, 2007 | 125MG/5ML, 250MG/5ML |
| AUROBINDO PHARMA LTD | 065489 | AB (A-rated, therapeutically equivalent) | July 25, 2012 | 250MG, 500MG |
| NOVITIUM PHARMA LLC | 202710 | AB (A-rated, therapeutically equivalent) | June 10, 2013 | 250MG, 500MG |
| HEC PHARM USA INC | 203584 | AB (A-rated, therapeutically equivalent) | September 28, 2015 | 250MG, 500MG |
| ALEMBIC PHARMACEUTICALS LTD | 210459 | AB (A-rated, therapeutically equivalent) | January 31, 2022 | 250MG, 500MG |
Questions
Is there a generic for Biaxin?
Yes. The generic name for Biaxin is clarithromycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Biaxin products the Orange Book lists.
What is the generic name for Biaxin?
The active ingredient in Biaxin 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.