FDA Orange Book

Generic for Nasonex

Nasonex 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

Yes. The generic name for Nasonex is mometasone furoate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Nasonex products in the Orange Book

Nasonex products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
spray, metered, nasal0.05MG/SPRAYDiscontinuedNone4AB

NDA 020762, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic mometasone furoate

Approved generic versions of Nasonex
CompanyANDATE codeApprovedStrengths
APOTEX INC091161AB (A-rated, therapeutically equivalent)March 22, 20160.05MG/SPRAY
AMNEAL PHARMACEUTICALS207989AB (A-rated, therapeutically equivalent)April 3, 20170.05MG/SPRAY
AUROBINDO PHARMA LTD215878AB (A-rated, therapeutically equivalent)March 18, 20240.05MG/SPRAY
NASPRESS PHARMACEUTICAL CO LTD211706AB (A-rated, therapeutically equivalent)May 15, 20250.05MG/SPRAY

Questions

Is there a generic for Nasonex?

Yes. The generic name for Nasonex is mometasone furoate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Nasonex?

The active ingredient in Nasonex 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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