FDA Orange Book
Generic for Keflex
Keflex contains cephalexin. 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 Keflex is cephalexin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 7 Keflex products the Orange Book lists.
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Keflex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 250MG BASE | Discontinued | None | 7 | AB |
| capsule, oral | EQ 333MG BASE | Discontinued | None | 1 | None |
| capsule, oral | EQ 500MG BASE | Discontinued | None | 7 | AB |
| capsule, oral | EQ 750MG BASE | Discontinued | None | 2 | AB |
| for suspension, oral | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | Discontinued | None | 0 | None |
| for suspension, oral | EQ 125MG BASE/5ML | Discontinued | None | 5 | AB |
| for suspension, oral | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | Discontinued | None | 0 | None |
NDA 050405, 050406, held by PRAGMA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cephalexin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 062702 | AB (A-rated, therapeutically equivalent) | February 13, 1987 | EQ 250MG BASE, EQ 500MG BASE |
| TEVA PHARMACEUTICALS USA INC | 062703 | AB (A-rated, therapeutically equivalent) | February 13, 1987 | EQ 125MG BASE/5ML |
| AJENAT PHARMACEUTICALS LLC | 062713 | AB (A-rated, therapeutically equivalent) | July 15, 1988 | EQ 250MG BASE, EQ 500MG BASE |
| CHARTWELL RX SCIENCES LLC | 065152 | AB (A-rated, therapeutically equivalent) | February 24, 2005 | EQ 250MG BASE, EQ 500MG BASE |
| ANDA REPOSITORY LLC | 065248 | AB (A-rated, therapeutically equivalent) | June 28, 2005 | EQ 250MG BASE, EQ 500MG BASE |
| LUPIN LTD | 065234 | AB (A-rated, therapeutically equivalent) | August 17, 2005 | EQ 125MG BASE/5ML |
| AUROBINDO PHARMA LTD | 065253 | AB (A-rated, therapeutically equivalent) | November 16, 2005 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| LUPIN LTD | 065229 | AB (A-rated, therapeutically equivalent) | November 25, 2005 | EQ 250MG BASE, EQ 500MG BASE |
| YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD | 065336 | AB (A-rated, therapeutically equivalent) | July 25, 2007 | EQ 125MG BASE/5ML |
| ALKEM LABORATORIES LTD | 090836 | AB (A-rated, therapeutically equivalent) | December 20, 2010 | EQ 250MG BASE, EQ 333MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| ALKEM LABORATORIES LTD | 210221 | AB (A-rated, therapeutically equivalent) | March 26, 2019 | EQ 125MG BASE/5ML |
| AUROBINDO PHARMA LTD | 213568 | AB (A-rated, therapeutically equivalent) | June 9, 2026 | EQ 125MG BASE/5ML |
Questions
Is there a generic for Keflex?
Yes. The generic name for Keflex is cephalexin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 7 Keflex products the Orange Book lists.
What is the generic name for Keflex?
The active ingredient in Keflex is cephalexin, 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.