FDA Orange Book
Generic for Sporanox
Sporanox contains itraconazole. 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 Sporanox is itraconazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 2 of the 3 Sporanox products the Orange Book lists.
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Sporanox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 7 | AB |
| injectable, injection | 10MG/ML | Discontinued | None | 0 | None |
| solution, oral | 10MG/ML | Discontinued | None | 2 | AA |
NDA 020083, 020966, 020657, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic itraconazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 076104 | AB (A-rated, therapeutically equivalent) | May 28, 2004 | 100MG |
| AMNEAL PHARMACEUTICALS | 205573 | AA (A-rated, therapeutically equivalent) | October 30, 2015 | 10MG/ML |
| AMNEAL PHARMACEUTICALS | 205080 | AB (A-rated, therapeutically equivalent) | September 26, 2016 | 100MG |
| ALEMBIC PHARMACEUTICALS LTD | 206741 | AB (A-rated, therapeutically equivalent) | December 13, 2016 | 100MG |
| RISING PHARMA HOLDINGS INC | 205724 | AB (A-rated, therapeutically equivalent) | December 13, 2016 | 100MG |
| ALKEM LABORATORIES LTD | 208591 | AB (A-rated, therapeutically equivalent) | June 12, 2017 | 100MG |
| ZYDUS PHARMACEUTICALS USA INC | 204672 | AB (A-rated, therapeutically equivalent) | September 19, 2017 | 100MG |
| TORRENT PHARMACEUTICALS LTD | 209460 | AB (A-rated, therapeutically equivalent) | August 24, 2018 | 100MG |
| ANNORA PHARMA PRIVATE LTD | 212239 | AA (A-rated, therapeutically equivalent) | September 1, 2020 | 10MG/ML |
Sporanox NDC codes
Questions
Is there a generic for Sporanox?
Yes. The generic name for Sporanox is itraconazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 2 of the 3 Sporanox products the Orange Book lists.
What is the generic name for Sporanox?
The active ingredient in Sporanox is itraconazole, 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.