FDA Orange Book
Generic for Ceftin
Ceftin contains cefuroxime axetil. 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 Ceftin is cefuroxime axetil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Ceftin products the Orange Book lists.
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Ceftin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | EQ 125MG BASE/5ML | Discontinued | None | 0 | None |
| for suspension, oral | EQ 250MG BASE/5ML | Discontinued | None | 0 | None |
| tablet, oral | EQ 125MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 250MG BASE | Discontinued | None | 4 | AB |
| tablet, oral | EQ 500MG BASE | Discontinued | None | 4 | AB |
NDA 050672, 050605, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefuroxime axetil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 065166 | AB (A-rated, therapeutically equivalent) | July 29, 2005 | EQ 125MG BASE, EQ 250MG BASE, EQ 500MG BASE |
| AUROBINDO PHARMA LTD | 065308 | AB (A-rated, therapeutically equivalent) | March 29, 2006 | EQ 125MG BASE, EQ 250MG BASE, EQ 500MG BASE |
| ANDA REPOSITORY LLC | 065359 | AB (A-rated, therapeutically equivalent) | February 15, 2008 | EQ 125MG BASE, EQ 250MG BASE, EQ 500MG BASE |
| ALKEM LABORATORIES LTD | 065496 | AB (A-rated, therapeutically equivalent) | June 7, 2010 | EQ 250MG BASE, EQ 500MG BASE |
Questions
Is there a generic for Ceftin?
Yes. The generic name for Ceftin is cefuroxime axetil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Ceftin products the Orange Book lists.
What is the generic name for Ceftin?
The active ingredient in Ceftin is cefuroxime axetil, 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.