FDA Orange Book
Generic for Femcon Fe
Femcon Fe contains norethindrone 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 Femcon Fe is norethindrone and ethinyl estradiol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Femcon Fe products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.035MG;0.4MG | Discontinued | None | 6 | AB |
NDA 021490, 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 and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 078965 | AB (A-rated, therapeutically equivalent) | August 5, 2010 | 0.035MG;0.4MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 078892 | AB (A-rated, therapeutically equivalent) | September 26, 2011 | 0.035MG;0.4MG |
| XIROMED LLC | 202086 | AB (A-rated, therapeutically equivalent) | April 1, 2015 | 0.035MG;0.4MG |
| LUPIN LTD | 091332 | AB (A-rated, therapeutically equivalent) | March 23, 2016 | 0.035MG;0.4MG |
| AUROBINDO PHARMA LTD | 207535 | AB (A-rated, therapeutically equivalent) | February 2, 2017 | 0.035MG;0.4MG |
| NAARI PTE LTD | 207066 | AB (A-rated, therapeutically equivalent) | March 29, 2017 | 0.035MG;0.4MG |
Questions
Is there a generic for Femcon Fe?
Yes. The generic name for Femcon Fe is norethindrone and ethinyl estradiol. 6 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 Femcon Fe?
The active ingredient in Femcon Fe is norethindrone 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.