FDA Orange Book
Generic for Diflucan
Diflucan contains fluconazole. 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 Diflucan is fluconazole. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Diflucan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 200MG/5ML | Marketed (Rx) | AB | 2 | AB |
| for suspension, oral | 50MG/5ML | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 100MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 150MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 200MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 7 | AB |
NDA 020090, 019949, held by PFIZER CHEMICALS DIV PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluconazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL LIFE MOLECULES LLC | 076665 | AB (A-rated, therapeutically equivalent) | July 29, 2004 | 100MG, 150MG, 200MG, 50MG |
| DR REDDYS LABORATORIES INC | 076658 | AB (A-rated, therapeutically equivalent) | July 29, 2004 | 100MG, 150MG, 200MG, 50MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 076957 | AB (A-rated, therapeutically equivalent) | September 28, 2005 | 100MG, 150MG, 200MG, 50MG |
| GLENMARK PHARMACEUTICALS LTD | 077253 | AB (A-rated, therapeutically equivalent) | January 25, 2006 | 100MG, 150MG, 200MG, 50MG |
| AUROBINDO PHARMA LTD | 077731 | AB (A-rated, therapeutically equivalent) | October 7, 2008 | 100MG, 150MG, 200MG, 50MG |
| AUROBINDO PHARMA LTD | 079150 | AB (A-rated, therapeutically equivalent) | September 18, 2009 | 200MG/5ML, 50MG/5ML |
| ANI PHARMACEUTICALS INC | 078423 | AB (A-rated, therapeutically equivalent) | March 7, 2011 | 100MG, 150MG, 200MG |
| ZYDUS PHARMACEUTICALS USA INC | 208963 | AB (A-rated, therapeutically equivalent) | February 16, 2017 | 100MG, 150MG, 200MG, 50MG |
| ZHEJIANG POLY PHARM CO LTD | 215738 | AB (A-rated, therapeutically equivalent) | September 21, 2023 | 200MG/5ML |
| FDC LTD | 218692 | AB (A-rated, therapeutically equivalent) | January 8, 2026 | 100MG, 150MG, 200MG, 50MG |
Diflucan NDC codes
Questions
Is there a generic for Diflucan?
Yes. The generic name for Diflucan is fluconazole. 9 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 Diflucan?
The active ingredient in Diflucan is fluconazole, 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.