FDA Orange Book
Generic for Ortho Cyclen-28
Ortho Cyclen-28 contains ethinyl estradiol and norgestimate. 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 Cyclen-28 is ethinyl estradiol and norgestimate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ortho Cyclen-28 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.035MG;0.25MG | Discontinued | None | 7 | AB |
NDA 019653, 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 ethinyl estradiol and norgestimate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 075804 | AB (A-rated, therapeutically equivalent) | September 25, 2002 | 0.035MG;0.25MG |
| GLENMARK PHARMACEUTICALS LTD | 200538 | AB (A-rated, therapeutically equivalent) | April 5, 2012 | 0.035MG;0.25MG |
| NOVAST LABORATORIES LTD | 090523 | AB (A-rated, therapeutically equivalent) | May 23, 2012 | 0.035MG;0.25MG |
| XIROMED PHARMA ESPANA SL | 090794 | AB (A-rated, therapeutically equivalent) | January 30, 2013 | 0.035MG;0.25MG |
| NAARI PTE LTD | 200384 | AB (A-rated, therapeutically equivalent) | April 7, 2015 | 0.035MG;0.25MG |
| AUROBINDO PHARMA LTD | 205449 | AB (A-rated, therapeutically equivalent) | July 7, 2016 | 0.035MG;0.25MG |
| LUPIN LTD | 205630 | AB (A-rated, therapeutically equivalent) | October 27, 2016 | 0.035MG;0.25MG |
Questions
Is there a generic for Ortho Cyclen-28?
Yes. The generic name for Ortho Cyclen-28 is ethinyl estradiol and norgestimate. 7 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 Cyclen-28?
The active ingredient in Ortho Cyclen-28 is ethinyl estradiol and norgestimate, 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.