FDA Orange Book
Generic for Nordette-28
Nordette-28 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 Nordette-28 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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Nordette-28 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.03MG;0.15MG | Discontinued | None | 8 | AB |
NDA 018782, 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 |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 073594 | AB (A-rated, therapeutically equivalent) | December 13, 1993 | 0.03MG;0.15MG |
| BARR LABORATORIES INC | 075866 | AB (A-rated, therapeutically equivalent) | May 23, 2002 | 0.03MG;0.15MG |
| XIROMED PHARMA ESPANA SL | 079102 | AB (A-rated, therapeutically equivalent) | August 3, 2010 | 0.03MG;0.15MG |
| GLENMARK PHARMACEUTICALS LTD | 091452 | AB (A-rated, therapeutically equivalent) | February 29, 2012 | 0.03MG;0.15MG |
| LUPIN LTD | 091408 | AB (A-rated, therapeutically equivalent) | October 17, 2012 | 0.03MG;0.15MG |
| XIROMED LLC | 091663 | AB (A-rated, therapeutically equivalent) | December 21, 2012 | 0.03MG;0.15MG |
| AUROBINDO PHARMA LTD | 206866 | AB (A-rated, therapeutically equivalent) | September 23, 2016 | 0.03MG;0.15MG |
| NAARI PTE LTD | 207033 | AB (A-rated, therapeutically equivalent) | October 9, 2020 | 0.03MG;0.15MG |
Questions
Is there a generic for Nordette-28?
Yes. The generic name for Nordette-28 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 Nordette-28?
The active ingredient in Nordette-28 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.