FDA Orange Book
Generic for Yaz
Yaz contains drospirenone and ethinyl estradiol. 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 Yaz is drospirenone and ethinyl estradiol. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Yaz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG;0.02MG | Marketed (Rx) | AB | 9 | AB |
NDA 021676, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic drospirenone and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| XIROMED PHARMA ESPANA SL | 079221 | AB (A-rated, therapeutically equivalent) | March 28, 2011 | 3MG;0.02MG |
| WATSON LABORATORIES INC | 078833 | AB (A-rated, therapeutically equivalent) | November 28, 2011 | 3MG;0.02MG |
| LUPIN LTD | 201661 | AB (A-rated, therapeutically equivalent) | May 27, 2014 | 3MG;0.02MG |
| GLENMARK PHARMACEUTICALS LTD | 204296 | AB (A-rated, therapeutically equivalent) | August 17, 2015 | 3MG;0.02MG |
| XIROMED LLC | 202594 | AB (A-rated, therapeutically equivalent) | October 22, 2015 | 3MG;0.02MG |
| NOVAST LABORATORIES LTD | 202016 | AB (A-rated, therapeutically equivalent) | January 26, 2016 | 3MG;0.02MG |
| PHARMOBEDIENT CONSULTING LLC | 203291 | AB (A-rated, therapeutically equivalent) | July 18, 2017 | 3MG;0.02MG |
| AUROBINDO PHARMA LTD | 209632 | AB (A-rated, therapeutically equivalent) | February 27, 2018 | 3MG;0.02MG |
| HETERO LABS LTD | 211944 | AB (A-rated, therapeutically equivalent) | March 22, 2019 | 3MG;0.02MG |
Questions
Is there a generic for Yaz?
Yes. The generic name for Yaz is drospirenone and ethinyl estradiol. 9 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 Yaz?
The active ingredient in Yaz is drospirenone and ethinyl estradiol, 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.