FDA Orange Book
Generic for Nilstat
Nilstat contains nystatin. 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 Nilstat is nystatin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 2 Nilstat products the Orange Book lists.
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Nilstat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral | 100% | Discontinued | None | 0 | None |
| suspension, oral | 100,000 UNITS/ML | Marketed (Rx) | AA | 6 | AA |
NDA 050576, 050299, held by STRIDES PHARMA INTERNATIONAL AG. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nystatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 062517 | AA (A-rated, therapeutically equivalent) | June 7, 1984 | 100,000 UNITS/ML |
| PHARMOBEDIENT CONSULTING LLC | 062512 | AA (A-rated, therapeutically equivalent) | October 29, 1984 | 100,000 UNITS/ML |
| SCIEGEN PHARMACEUTICALS INC | 062832 | AA (A-rated, therapeutically equivalent) | December 27, 1991 | 100,000 UNITS/ML |
| GENUS LIFESCIENCES INC | 065148 | AA (A-rated, therapeutically equivalent) | June 28, 2005 | 100,000 UNITS/ML |
| PHARMACEUTICAL ASSOCIATES INC | 203621 | AA (A-rated, therapeutically equivalent) | January 7, 2016 | 100,000 UNITS/ML |
| PHARMAZONE | 214346 | AA (A-rated, therapeutically equivalent) | March 10, 2022 | 100,000 UNITS/ML |
Nilstat NDC codes
Questions
Is there a generic for Nilstat?
Yes. The generic name for Nilstat is nystatin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 2 Nilstat products the Orange Book lists.
What is the generic name for Nilstat?
The active ingredient in Nilstat is nystatin, 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.