FDA Orange Book
Is there a generic for Ertaczo?
Ertaczo contains sertaconazole nitrate. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ertaczo (sertaconazole nitrate).
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Ertaczo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 2% | Marketed (Rx) | None | 0 | None |
NDA 021385, held by LACER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ertaczo NDC codes
Questions
Is there a generic for Ertaczo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ertaczo (sertaconazole nitrate).
What is the generic name for Ertaczo?
The active ingredient in Ertaczo is sertaconazole nitrate, 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.