FDA Orange Book
Generic for Nizoral
Nizoral contains ketoconazole. 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 Nizoral is ketoconazole. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Nizoral products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 2% | Discontinued | None | 4 | AB |
| shampoo, topical | 2% | Discontinued | None | 4 | AB |
| tablet, oral | 200MG | Discontinued | None | 4 | AB |
NDA 019084, 019927, 018533, held by JANSSEN PHARMACEUTICA PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ketoconazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075319 | AB (A-rated, therapeutically equivalent) | June 15, 1999 | 200MG |
| TEVA PHARMACEUTICALS USA INC | 075581 | AB (A-rated, therapeutically equivalent) | April 25, 2000 | 2% |
| PHARMAZONE | 075912 | AB (A-rated, therapeutically equivalent) | January 10, 2002 | 200MG |
| SUN PHARMA CANADA INC | 075638 | AB (A-rated, therapeutically equivalent) | December 18, 2002 | 2% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076419 | AB (A-rated, therapeutically equivalent) | January 7, 2004 | 2% |
| FOUGERA PHARMACEUTICALS INC | 076294 | AB (A-rated, therapeutically equivalent) | April 28, 2004 | 2% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 076942 | AB (A-rated, therapeutically equivalent) | April 11, 2005 | 2% |
| STRIDES PHARMA GLOBAL PTE LTD | 210457 | AB (A-rated, therapeutically equivalent) | June 18, 2018 | 200MG |
| ENCUBE ETHICALS PRIVATE LTD | 212443 | AB (A-rated, therapeutically equivalent) | May 20, 2021 | 2% |
| NOVITIUM PHARMA LLC | 218498 | AB (A-rated, therapeutically equivalent) | September 16, 2024 | 2% |
| ZYDUS LIFESCIENCES LTD | 218559 | AB (A-rated, therapeutically equivalent) | March 7, 2025 | 2% |
| NOVITIUM PHARMA LLC | 219129 | AB (A-rated, therapeutically equivalent) | July 3, 2025 | 200MG |
Questions
Is there a generic for Nizoral?
Yes. The generic name for Nizoral is ketoconazole. 11 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 Nizoral?
The active ingredient in Nizoral is ketoconazole, 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.