FDA Orange Book
Is there a generic for Dulera?
Dulera contains mometasone furoate and formoterol. 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 Dulera (mometasone furoate and formoterol).
Run it in Rivvi
Map Dulera 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.
Dulera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.005MG/INH;0.05MG/INH | Marketed (Rx) | None | 0 | None |
| aerosol, metered, inhalation | 0.005MG/INH;0.1MG/INH | Marketed (Rx) | None | 0 | None |
| aerosol, metered, inhalation | 0.005MG/INH;0.2MG/INH | Marketed (Rx) | None | 0 | None |
NDA 022518, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Dulera NDC codes
Questions
Is there a generic for Dulera?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dulera (mometasone furoate and formoterol).
What is the generic name for Dulera?
The active ingredient in Dulera is mometasone furoate and formoterol, 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.