FDA Orange Book
Generic for Accolate
Accolate contains zafirlukast. 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 Accolate is zafirlukast. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Accolate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 4 | AB |
NDA 020547, held by STRIDES PHARMA INTERNATIONAL AG. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic zafirlukast
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 090372 | AB (A-rated, therapeutically equivalent) | November 18, 2010 | 10MG, 20MG |
| ANNORA PHARMA PRIVATE LTD | 212475 | AB (A-rated, therapeutically equivalent) | September 10, 2020 | 10MG, 20MG |
| RISING PHARMACEUTICALS INC | 204928 | AB (A-rated, therapeutically equivalent) | August 25, 2022 | 10MG, 20MG |
| AUROBINDO PHARMA LTD | 213163 | AB (A-rated, therapeutically equivalent) | November 27, 2023 | 10MG, 20MG |
Accolate NDC codes
Questions
Is there a generic for Accolate?
Yes. The generic name for Accolate is zafirlukast. 4 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 Accolate?
The active ingredient in Accolate is zafirlukast, 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.