FDA Orange Book
Generic for Femara
Femara contains letrozole. 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 Femara is letrozole. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Femara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 7 | AB |
NDA 020726, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic letrozole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 090934 | AB (A-rated, therapeutically equivalent) | June 3, 2011 | 2.5MG |
| NATCO PHARMA LTD | 200161 | AB (A-rated, therapeutically equivalent) | June 3, 2011 | 2.5MG |
| PHARMOBEDIENT CONSULTING LLC | 091191 | AB (A-rated, therapeutically equivalent) | June 3, 2011 | 2.5MG |
| TEVA PHARMACEUTICALS USA | 090289 | AB (A-rated, therapeutically equivalent) | June 3, 2011 | 2.5MG |
| PHARMOBEDIENT CONSULTING LLC | 205869 | AB (A-rated, therapeutically equivalent) | November 14, 2018 | 2.5MG |
| EUGIA PHARMA SPECIALITIES LTD | 211717 | AB (A-rated, therapeutically equivalent) | January 11, 2019 | 2.5MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 220438 | AB (A-rated, therapeutically equivalent) | September 14, 2026 | 2.5MG |
Femara NDC codes
Questions
Is there a generic for Femara?
Yes. The generic name for Femara is letrozole. 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 Femara?
The active ingredient in Femara is letrozole, 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.