FDA Orange Book
Generic for Diflucan in Sodium Chloride
Diflucan in Sodium Chloride 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 in Sodium Chloride is fluconazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Diflucan in Sodium Chloride products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 200MG/100ML (2MG/ML) | Discontinued | None | 9 | AP |
| injectable, injection | 400MG/200ML (2MG/ML) | Discontinued | None | 8 | AP |
NDA 019950, held by 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 |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 076145 | AP (A-rated, therapeutically equivalent) | July 29, 2004 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 076087 | AP (A-rated, therapeutically equivalent) | July 29, 2004 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| BAXTER HEALTHCARE CORP | 076766 | AP (A-rated, therapeutically equivalent) | July 29, 2004 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| HOSPIRA INC | 076303 | AP (A-rated, therapeutically equivalent) | July 29, 2004 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| HIKMA FARMACEUTICA PORTUGAL LDA | 076736 | AP (A-rated, therapeutically equivalent) | August 23, 2005 | 200MG/100ML (2MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 078107 | AP (A-rated, therapeutically equivalent) | July 30, 2008 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| INFORLIFE SA | 079104 | AP (A-rated, therapeutically equivalent) | July 30, 2009 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| WOODWARD PHARMA SERVICES LLC | 077909 | AP (A-rated, therapeutically equivalent) | May 26, 2010 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078698 | AP (A-rated, therapeutically equivalent) | January 30, 2012 | 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML) |
Questions
Is there a generic for Diflucan in Sodium Chloride?
Yes. The generic name for Diflucan in Sodium Chloride is fluconazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Diflucan in Sodium Chloride?
The active ingredient in Diflucan in Sodium Chloride 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.