FDA Orange Book
Generic for Zofran ODT
Zofran ODT 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 ODT is ondansetron. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zofran ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 4MG | Discontinued | None | 6 | AB |
| tablet, orally disintegrating, oral | 8MG | Discontinued | None | 6 | AB |
NDA 020781, 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 |
|---|---|---|---|---|
| CHARTWELL MOLECULES LLC | 077406 | AB (A-rated, therapeutically equivalent) | December 26, 2006 | 4MG, 8MG |
| GLENMARK PHARMACEUTICALS LTD | 078152 | AB (A-rated, therapeutically equivalent) | June 27, 2007 | 4MG, 8MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 077557 | AB (A-rated, therapeutically equivalent) | August 2, 2007 | 4MG, 8MG |
| SANDOZ INC | 078050 | AB (A-rated, therapeutically equivalent) | August 13, 2007 | 4MG, 8MG |
| AUROBINDO PHARMA LTD | 090469 | AB (A-rated, therapeutically equivalent) | April 12, 2010 | 4MG, 8MG |
| IPCA LABORATORIES LTD | 209389 | AB (A-rated, therapeutically equivalent) | October 30, 2023 | 4MG, 8MG |
Questions
Is there a generic for Zofran ODT?
Yes. The generic name for Zofran ODT is ondansetron. 6 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 Zofran ODT?
The active ingredient in Zofran ODT 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.