FDA Orange Book
Generic for Femhrt
Femhrt 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 Femhrt is norethindrone acetate and ethinyl estradiol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Femhrt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.0025MG;0.5MG | Discontinued | None | 3 | AB |
| tablet, oral | 0.005MG;1MG | Discontinued | None | 4 | AB |
NDA 021065, held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD. 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 INC | 076221 | AB (A-rated, therapeutically equivalent) | November 6, 2009 | 0.005MG;1MG |
| GLENMARK PHARMACEUTICALS LTD | 203038 | AB (A-rated, therapeutically equivalent) | April 2, 2015 | 0.0025MG;0.5MG, 0.005MG;1MG |
| LUPIN LTD | 204213 | AB (A-rated, therapeutically equivalent) | December 10, 2015 | 0.0025MG;0.5MG, 0.005MG;1MG |
| NOVAST LABORATORIES LTD | 203435 | AB (A-rated, therapeutically equivalent) | June 3, 2016 | 0.0025MG;0.5MG, 0.005MG;1MG |
Questions
Is there a generic for Femhrt?
Yes. The generic name for Femhrt is norethindrone acetate and ethinyl estradiol. 4 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 Femhrt?
The active ingredient in Femhrt 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.