FDA Orange Book
Is there a generic for Tri-luma?
Tri-luma contains fluocinolone acetonide, hydroquinone and tretinoin. 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 Tri-luma (fluocinolone acetonide, hydroquinone and tretinoin).
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Tri-luma products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.01%;4%;0.05% | Marketed (Rx) | None | 0 | None |
NDA 021112, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tri-luma NDC codes
Questions
Is there a generic for Tri-luma?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tri-luma (fluocinolone acetonide, hydroquinone and tretinoin).
What is the generic name for Tri-luma?
The active ingredient in Tri-luma is fluocinolone acetonide, hydroquinone and tretinoin, 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.