FDA Orange Book

Is there a generic for Asmanex HFA?

Asmanex HFA contains mometasone furoate. 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 Asmanex HFA (mometasone furoate).

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Asmanex HFA products in the Orange Book

Asmanex HFA products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
aerosol, metered, inhalation0.05MG/INHMarketed (Rx)None0None
aerosol, metered, inhalation0.10MG/INHMarketed (Rx)None0None
aerosol, metered, inhalation0.20MG/INHMarketed (Rx)None0None

NDA 205641, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Asmanex HFA NDC codes

Questions

Is there a generic for Asmanex HFA?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Asmanex HFA (mometasone furoate).

What is the generic name for Asmanex HFA?

The active ingredient in Asmanex HFA is mometasone furoate, 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.

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