FDA Orange Book
Generic for Zofran
Zofran contains ondansetron. 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 Zofran is ondansetron. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
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Zofran products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 2MG BASE/ML | Discontinued | None | 18 | AP |
| solution, oral | EQ 4MG BASE/5ML | Discontinued | None | 5 | AA |
| tablet, oral | EQ 24MG BASE | Discontinued | None | 1 | None |
| tablet, oral | EQ 4MG BASE | Discontinued | None | 6 | AB |
| tablet, oral | EQ 8MG BASE | Discontinued | None | 6 | AB |
NDA 020007, 020605, 020103, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ondansetron
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 076974 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 076967 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 077365 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HOSPIRA INC | 077473 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| WOCKHARDT BIO AG | 077577 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 076972 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 077011 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 077541 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HOSPIRA INC | 077548 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| WOCKHARDT BIO AG | 077716 | AP (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 076960 | AA (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 4MG BASE/5ML |
| DR REDDYS LABORATORIES LTD | 076183 | AB (A-rated, therapeutically equivalent) | December 26, 2006 | EQ 4MG BASE, EQ 8MG BASE |
| PHARMACEUTICAL ASSOCIATES INC | 078127 | AA (A-rated, therapeutically equivalent) | June 25, 2007 | EQ 4MG BASE/5ML |
| CHARTWELL MOLECULES LLC | 077303 | None (No TE code listed) | June 25, 2007 | EQ 24MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 077535 | AB (A-rated, therapeutically equivalent) | June 25, 2007 | EQ 4MG BASE, EQ 8MG BASE |
| NATCO PHARMA LTD | 077851 | AB (A-rated, therapeutically equivalent) | June 25, 2007 | EQ 4MG BASE, EQ 8MG BASE |
| SANDOZ INC | 077430 | AP (A-rated, therapeutically equivalent) | June 27, 2007 | EQ 2MG BASE/ML |
| SANDOZ INC | 077551 | AP (A-rated, therapeutically equivalent) | June 27, 2007 | EQ 2MG BASE/ML |
| AUROBINDO PHARMA LTD | 078539 | AB (A-rated, therapeutically equivalent) | July 31, 2007 | EQ 4MG BASE, EQ 8MG BASE |
| AUROBINDO PHARMA LTD | 078776 | AA (A-rated, therapeutically equivalent) | November 28, 2007 | EQ 4MG BASE/5ML |
| GLAND PHARMA LTD | 079224 | AP (A-rated, therapeutically equivalent) | September 25, 2009 | EQ 2MG BASE/ML |
| CHARTWELL MOLECULAR HOLDINGS LLC | 091342 | AA (A-rated, therapeutically equivalent) | January 27, 2011 | EQ 4MG BASE/5ML |
| AMNEAL PHARMACEUTICALS | 091483 | AA (A-rated, therapeutically equivalent) | January 31, 2011 | EQ 4MG BASE/5ML |
| GLAND PHARMA LTD | 090648 | AP (A-rated, therapeutically equivalent) | June 15, 2012 | EQ 2MG BASE/ML |
| BAXTER HEALTHCARE CORP | 078287 | AP (A-rated, therapeutically equivalent) | February 22, 2013 | EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 202253 | AP (A-rated, therapeutically equivalent) | July 19, 2013 | EQ 2MG BASE/ML |
| IPCA LABORATORIES LTD | 203761 | AB (A-rated, therapeutically equivalent) | January 23, 2014 | EQ 4MG BASE, EQ 8MG BASE |
| QILU PHARMACEUTICAL HAINAN CO LTD | 203711 | AP (A-rated, therapeutically equivalent) | September 8, 2014 | EQ 2MG BASE/ML |
| ACCORD HEALTHCARE INC | 206846 | AP (A-rated, therapeutically equivalent) | July 13, 2015 | EQ 2MG BASE/ML |
Questions
Is there a generic for Zofran?
Yes. The generic name for Zofran is ondansetron. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Zofran?
The active ingredient in Zofran is ondansetron, 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.