FDA Orange Book
Generic for Lybrel
Lybrel contains levonorgestrel 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 Lybrel is levonorgestrel and ethinyl estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lybrel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.02MG;0.09MG | Discontinued | None | 3 | AB |
NDA 021864, held by WYETH PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levonorgestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 079218 | AB (A-rated, therapeutically equivalent) | June 6, 2011 | 0.02MG;0.09MG |
| GLENMARK PHARMACEUTICALS LTD | 202791 | AB (A-rated, therapeutically equivalent) | April 9, 2015 | 0.02MG;0.09MG |
| NOVAST LABORATORIES LTD | 091692 | AB (A-rated, therapeutically equivalent) | October 22, 2020 | 0.02MG;0.09MG |
Questions
Is there a generic for Lybrel?
Yes. The generic name for Lybrel is levonorgestrel and ethinyl estradiol. 3 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 Lybrel?
The active ingredient in Lybrel is levonorgestrel 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.