FDA Orange Book
Generic for Ortho Tri-cyclen Lo
Ortho Tri-cyclen Lo 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 Tri-cyclen Lo 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 Tri-cyclen Lo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | Discontinued | None | 7 | AB |
NDA 021241, 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 | 076784 | AB (A-rated, therapeutically equivalent) | June 29, 2009 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
| LUPIN PHARMACEUTICALS INC | 200541 | AB (A-rated, therapeutically equivalent) | June 25, 2012 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
| XIROMED PHARMA ESPANA SL | 091232 | AB (A-rated, therapeutically equivalent) | June 29, 2015 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
| GLENMARK SPECIALTY SA | 204057 | AB (A-rated, therapeutically equivalent) | February 23, 2016 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
| NAARI PTE LTD | 203873 | AB (A-rated, therapeutically equivalent) | May 12, 2016 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
| AUROBINDO PHARMA LTD | 205762 | AB (A-rated, therapeutically equivalent) | November 4, 2016 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
| NOVAST LABORATORIES LTD | 090541 | AB (A-rated, therapeutically equivalent) | September 2, 2022 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Questions
Is there a generic for Ortho Tri-cyclen Lo?
Yes. The generic name for Ortho Tri-cyclen Lo 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 Tri-cyclen Lo?
The active ingredient in Ortho Tri-cyclen Lo 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.