FDA Orange Book
Generic for Ortho-cept
Ortho-cept contains desogestrel 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 Ortho-cept is desogestrel 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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Ortho-cept products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.15MG;0.03MG | Discontinued | None | 1 | None |
| tablet, oral-28 | 0.15MG;0.03MG | Discontinued | None | 9 | AB |
NDA 020301, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desogestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC | 075256 | AB (A-rated, therapeutically equivalent) | August 12, 1999 | 0.15MG;0.03MG |
| WATSON LABORATORIES INC | 076915 | AB (A-rated, therapeutically equivalent) | July 29, 2005 | 0.15MG;0.03MG |
| LUPIN LTD | 201887 | AB (A-rated, therapeutically equivalent) | March 7, 2013 | 0.15MG;0.03MG |
| NOVAST LABORATORIES LTD | 091234 | AB (A-rated, therapeutically equivalent) | July 12, 2013 | 0.15MG;0.03MG |
| XIROMED PHARMA ESPANA SL | 202789 | AB (A-rated, therapeutically equivalent) | August 12, 2015 | 0.15MG;0.03MG |
| AUROBINDO PHARMA LTD | 207081 | AB (A-rated, therapeutically equivalent) | May 17, 2017 | 0.15MG;0.03MG |
| NAARI PTE LTD | 207067 | AB (A-rated, therapeutically equivalent) | September 13, 2018 | 0.15MG;0.03MG |
| AVION PHARMACEUTICALS LLC | 218933 | None (No TE code listed) | May 2, 2025 | 0.15MG;0.03MG, 0.15MG;0.03MG |
| ANNORA PHARMA PRIVATE LTD | 219761 | AB (A-rated, therapeutically equivalent) | March 18, 2026 | 0.15MG;0.03MG |
Questions
Is there a generic for Ortho-cept?
Yes. The generic name for Ortho-cept is desogestrel 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 Ortho-cept?
The active ingredient in Ortho-cept is desogestrel 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.