FDA Orange Book
Generic for Lamisil
Lamisil contains terbinafine. 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 Lamisil is terbinafine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 6 Lamisil products the Orange Book lists.
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Lamisil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Discontinued | None | 0 | None |
| gel, topical | 1% | Discontinued | None | 0 | None |
| granule, oral | EQ 125MG BASE/PACKET | Discontinued | None | 0 | None |
| granule, oral | EQ 187.5MG BASE/PACKET | Discontinued | None | 0 | None |
| solution, topical | 1% | Discontinued | None | 0 | None |
| tablet, oral | EQ 250MG BASE | Discontinued | None | 7 | AB |
NDA 020192, 020846, 022071, 020749, 020539, held by KARO HEALTHCARE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic terbinafine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 078297 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
| CHARTWELL LIFE MOLECULES LLC | 078199 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
| CIPLA LTD | 077137 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
| EMED MEDICAL CO LLC | 077919 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 078157 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
| ORBION PHARMACEUTICALS PRIVATE LTD | 078163 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
| PHARMAZONE | 076390 | AB (A-rated, therapeutically equivalent) | July 2, 2007 | EQ 250MG BASE |
Questions
Is there a generic for Lamisil?
Yes. The generic name for Lamisil is terbinafine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 6 Lamisil products the Orange Book lists.
What is the generic name for Lamisil?
The active ingredient in Lamisil is terbinafine, 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.