FDA Orange Book
Generic for Cefzil
Cefzil contains cefprozil. 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 Cefzil is cefprozil. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cefzil 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 | 2 | AB |
| for suspension, oral | 250MG/5ML | Discontinued | None | 2 | AB |
| tablet, oral | 250MG | Discontinued | None | 5 | AB |
| tablet, oral | 500MG | Discontinued | None | 5 | AB |
NDA 050665, 050664, held by CORDEN PHARMA LATINA SPA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefprozil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 065235 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | 250MG, 500MG |
| TEVA PHARMACEUTICALS USA INC | 065208 | AB (A-rated, therapeutically equivalent) | December 6, 2005 | 250MG, 500MG |
| LUPIN LTD | 065276 | AB (A-rated, therapeutically equivalent) | December 8, 2005 | 250MG, 500MG |
| LUPIN LTD | 065261 | AB (A-rated, therapeutically equivalent) | December 19, 2005 | 125MG/5ML, 250MG/5ML |
| AUROBINDO PHARMA LTD | 065381 | AB (A-rated, therapeutically equivalent) | January 30, 2007 | 125MG/5ML, 250MG/5ML |
| AUROBINDO PHARMA LTD | 065340 | AB (A-rated, therapeutically equivalent) | May 24, 2007 | 250MG, 500MG |
| ALKEM LABORATORIES LTD | 090857 | AB (A-rated, therapeutically equivalent) | April 9, 2024 | 250MG, 500MG |
Questions
Is there a generic for Cefzil?
Yes. The generic name for Cefzil is cefprozil. 5 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 Cefzil?
The active ingredient in Cefzil is cefprozil, 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.