FDA Orange Book
Generic for Seasonale
Seasonale 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 Seasonale is levonorgestrel and ethinyl estradiol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Seasonale products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.03MG;0.15MG | Marketed (Rx) | AB | 8 | AB |
NDA 021544, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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 | 077101 | AB (A-rated, therapeutically equivalent) | September 6, 2006 | 0.03MG;0.15MG |
| XIROMED PHARMA ESPANA SL | 079064 | AB (A-rated, therapeutically equivalent) | September 27, 2010 | 0.03MG;0.15MG |
| LUPIN LTD | 091440 | AB (A-rated, therapeutically equivalent) | October 23, 2012 | 0.03MG;0.15MG |
| NOVAST LABORATORIES LTD | 090716 | AB (A-rated, therapeutically equivalent) | September 15, 2014 | 0.03MG;0.15MG |
| XIROMED LLC | 200490 | AB (A-rated, therapeutically equivalent) | April 21, 2015 | 0.03MG;0.15MG |
| GLENMARK PHARMACEUTICALS LTD | 203164 | AB (A-rated, therapeutically equivalent) | June 12, 2015 | 0.03MG;0.15MG |
| NAARI PTE LTD | 203871 | AB (A-rated, therapeutically equivalent) | November 13, 2015 | 0.03MG;0.15MG |
| AUROBINDO PHARMA LTD | 206850 | AB (A-rated, therapeutically equivalent) | June 29, 2018 | 0.03MG;0.15MG |
Questions
Is there a generic for Seasonale?
Yes. The generic name for Seasonale is levonorgestrel and ethinyl estradiol. 8 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 Seasonale?
The active ingredient in Seasonale 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.