FDA Orange Book
Is there a generic for Sulfamylon?
Sulfamylon contains mafenide acetate. 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 Sulfamylon (mafenide acetate).
Run it in Rivvi
Map Sulfamylon and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Sulfamylon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 85MG BASE/GM | Marketed (Rx) | None | 0 | None |
| for solution, topical | 5% | Discontinued | None | 0 | None |
NDA 016763, 019832, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sulfamylon NDC codes
Questions
Is there a generic for Sulfamylon?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sulfamylon (mafenide acetate).
What is the generic name for Sulfamylon?
The active ingredient in Sulfamylon is mafenide acetate, 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.