FDA Orange Book
Generic for FeraBright
FeraBright 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 FeraBright is ferumoxytol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 FeraBright products the Orange Book lists.
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FeraBright products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 300MG IRON/10ML (EQ 30MG IRON/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | Marketed (Rx) | None | 1 | AB |
NDA 219868, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 206604 | AB (A-rated, therapeutically equivalent) | January 15, 2021 | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) |
FeraBright exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 16, 2028 | 219868 |
FeraBright NDC codes
Questions
Is there a generic for FeraBright?
Yes. The generic name for FeraBright is ferumoxytol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 FeraBright products the Orange Book lists.
What is the generic name for FeraBright?
The active ingredient in FeraBright 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.