FDA Orange Book
Generic for Sarafem
Sarafem contains fluoxetine. 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 Sarafem is fluoxetine. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1. Generics match 4 of the 5 Sarafem products the Orange Book lists.
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Sarafem products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Discontinued | None | 11 | AB1 |
| capsule, oral | EQ 20MG BASE | Discontinued | None | 11 | AB1 |
| tablet, oral | EQ 10MG BASE | Discontinued | None | 8 | AB |
| tablet, oral | EQ 15MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Discontinued | None | 8 | AB |
NDA 018936, 021860, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluoxetine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMAZONE | 075049 | AB1 (A-rated, therapeutically equivalent) | August 2, 2001 | EQ 10MG BASE, EQ 20MG BASE |
| PHARMAZONE | 075465 | AB1 (A-rated, therapeutically equivalent) | January 29, 2002 | EQ 10MG BASE, EQ 20MG BASE |
| TEVA PHARMACEUTICALS USA INC | 075452 | AB1 (A-rated, therapeutically equivalent) | January 29, 2002 | EQ 10MG BASE, EQ 20MG BASE |
| TEVA PHARMACEUTICALS USA | 076001 | AB1 (A-rated, therapeutically equivalent) | January 29, 2002 | EQ 10MG BASE, EQ 20MG BASE |
| LANDELA PHARMACEUTICAL | 075464 | AB1 (A-rated, therapeutically equivalent) | January 30, 2002 | EQ 10MG BASE, EQ 20MG BASE |
| DR REDDYS LABORATORIES LTD | 076006 | AB (A-rated, therapeutically equivalent) | January 30, 2002 | EQ 10MG BASE, EQ 20MG BASE |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 075245 | AB1 (A-rated, therapeutically equivalent) | January 31, 2002 | EQ 10MG BASE, EQ 20MG BASE |
| AUROBINDO PHARMA LTD | 078619 | AB1 (A-rated, therapeutically equivalent) | January 31, 2008 | EQ 10MG BASE, EQ 20MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 090223 | AB1 (A-rated, therapeutically equivalent) | March 19, 2009 | EQ 10MG BASE, EQ 20MG BASE |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 201336 | AB1 (A-rated, therapeutically equivalent) | October 1, 2012 | EQ 10MG BASE, EQ 20MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 204597 | AB1 (A-rated, therapeutically equivalent) | March 16, 2015 | EQ 10MG BASE, EQ 20MG BASE |
| PH HEALTH LTD | 203836 | AB (A-rated, therapeutically equivalent) | August 19, 2016 | EQ 10MG BASE, EQ 20MG BASE |
| TORRENT PHARMACEUTICALS LTD | 206937 | None (No TE code listed) | October 21, 2016 | EQ 10MG BASE, EQ 20MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 208698 | AB (A-rated, therapeutically equivalent) | April 5, 2017 | EQ 10MG BASE, EQ 20MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 210935 | AB (A-rated, therapeutically equivalent) | March 20, 2019 | EQ 10MG BASE, EQ 20MG BASE |
| LUPIN LTD | 211653 | AB (A-rated, therapeutically equivalent) | April 15, 2019 | EQ 10MG BASE, EQ 20MG BASE |
| CADILA PHARMACEUTICALS LTD | 206993 | AB1 (A-rated, therapeutically equivalent) | May 23, 2019 | EQ 10MG BASE, EQ 20MG BASE |
| AUROBINDO PHARMA LTD | 213286 | AB (A-rated, therapeutically equivalent) | April 8, 2020 | EQ 10MG BASE, EQ 20MG BASE |
| STRIDES PHARMA GLOBAL PTE LTD | 212684 | AB (A-rated, therapeutically equivalent) | April 5, 2024 | EQ 10MG BASE, EQ 20MG BASE |
Sarafem NDC codes
Questions
Is there a generic for Sarafem?
Yes. The generic name for Sarafem is fluoxetine. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1. Generics match 4 of the 5 Sarafem products the Orange Book lists.
What is the generic name for Sarafem?
The active ingredient in Sarafem is fluoxetine, 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.