FDA Orange Book

Generic for Feraheme

Feraheme contains ferumoxytol. 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 Feraheme is ferumoxytol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Feraheme products in the Orange Book

Feraheme products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravenousEQ 510MG IRON/17ML (EQ 30MG IRON/ML)Marketed (Rx)AB1AB

NDA 022180, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ferumoxytol

Approved generic versions of Feraheme
CompanyANDATE codeApprovedStrengths
SANDOZ INC206604AB (A-rated, therapeutically equivalent)January 15, 2021EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Feraheme NDC codes

Questions

Is there a generic for Feraheme?

Yes. The generic name for Feraheme is ferumoxytol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Feraheme?

The active ingredient in Feraheme is ferumoxytol, 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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