FDA Orange Book
Generic for Loestrin 21 1/20
Loestrin 21 1/20 contains norethindrone acetate 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 Loestrin 21 1/20 is norethindrone acetate and ethinyl estradiol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Loestrin 21 1/20 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.02MG;1MG | Discontinued | None | 5 | AB |
NDA 017876, 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 norethindrone acetate and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) | 076380 | AB (A-rated, therapeutically equivalent) | May 30, 2003 | 0.02MG;1MG |
| XIROMED LLC | 202771 | AB (A-rated, therapeutically equivalent) | November 6, 2013 | 0.02MG;1MG |
| NOVAST LABORATORIES LTD | 202995 | AB (A-rated, therapeutically equivalent) | December 4, 2013 | 0.02MG;1MG |
| GLENMARK PHARMACEUTICALS LTD | 206969 | AB (A-rated, therapeutically equivalent) | January 20, 2016 | 0.02MG;1MG |
| AUROBINDO PHARMA LTD | 207506 | AB (A-rated, therapeutically equivalent) | June 16, 2017 | 0.02MG;1MG |
Questions
Is there a generic for Loestrin 21 1/20?
Yes. The generic name for Loestrin 21 1/20 is norethindrone acetate and ethinyl estradiol. 5 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 Loestrin 21 1/20?
The active ingredient in Loestrin 21 1/20 is norethindrone acetate 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.