FDA Orange Book
Is there a generic for Tolak?
Tolak contains fluorouracil. 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 Tolak (fluorouracil).
Run it in Rivvi
Map Tolak 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.
Tolak products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 4% | Marketed (Rx) | None | 0 | None |
NDA 022259, held by HILL DERMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tolak NDC codes
Questions
Is there a generic for Tolak?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tolak (fluorouracil).
What is the generic name for Tolak?
The active ingredient in Tolak is fluorouracil, 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.