FDA Orange Book
Is there a generic for Thermazene?
Thermazene contains silver sulfadiazine. 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 Thermazene (silver sulfadiazine).
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Thermazene products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | AB | 0 | None |
NDA 018810, held by THEPHARMANETWORK LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Thermazene NDC codes
Questions
Is there a generic for Thermazene?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Thermazene (silver sulfadiazine).
What is the generic name for Thermazene?
The active ingredient in Thermazene is silver sulfadiazine, 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.