FDA Orange Book
Generic for Venofer
Venofer contains iron sucrose. 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 Venofer is iron sucrose. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Venofer products the Orange Book lists.
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Venofer products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | Marketed (Rx) | AB | 3 | AB |
| injectable, intravenous | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | Marketed (Rx) | AB | 3 | AB |
| injectable, intravenous | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | Marketed (Rx) | AB | 2 | AB |
| injectable, intravenous | EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) | Discontinued | None | 0 | None |
| injectable, intravenous | EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) | Discontinued | None | 0 | None |
NDA 021135, held by AMERICAN REGENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic iron sucrose
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| INTERNATIONAL MEDICATION SYSTEMS LTD | 208977 | AB (A-rated, therapeutically equivalent) | August 8, 2025 | EQ 100MG IRON/5ML (EQ 20MG IRON/ML), EQ 200MG IRON/10ML (EQ 20MG IRON/ML), EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) |
| MYLAN LABORATORIES LTD | 212559 | AB (A-rated, therapeutically equivalent) | August 8, 2025 | EQ 100MG IRON/5ML (EQ 20MG IRON/ML), EQ 200MG IRON/10ML (EQ 20MG IRON/ML) |
| SANDOZ INC | 212340 | AB (A-rated, therapeutically equivalent) | August 8, 2025 | EQ 100MG IRON/5ML (EQ 20MG IRON/ML), EQ 200MG IRON/10ML (EQ 20MG IRON/ML), EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) |
Venofer NDC codes
Questions
Is there a generic for Venofer?
Yes. The generic name for Venofer is iron sucrose. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Venofer products the Orange Book lists.
What is the generic name for Venofer?
The active ingredient in Venofer is iron sucrose, 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.