FDA Orange Book
Generic for Keflet
Keflet 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 Keflet is cephalexin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Keflet products the Orange Book lists.
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Keflet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 1GM BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 250MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 500MG BASE | Discontinued | None | 3 | AB |
NDA 050440, 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 cephalexin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 063024 | AB (A-rated, therapeutically equivalent) | January 12, 1989 | EQ 250MG BASE, EQ 500MG BASE |
| ALKEM LABORATORIES LTD | 218947 | AB (A-rated, therapeutically equivalent) | September 27, 2024 | EQ 250MG BASE, EQ 500MG BASE |
| AUROBINDO PHARMA LTD | 218817 | AB (A-rated, therapeutically equivalent) | September 27, 2024 | EQ 250MG BASE, EQ 500MG BASE |
Questions
Is there a generic for Keflet?
Yes. The generic name for Keflet is cephalexin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Keflet products the Orange Book lists.
What is the generic name for Keflet?
The active ingredient in Keflet 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.