FDA Orange Book
Generic for Ferrlecit
Ferrlecit contains sodium ferric gluconate complex. 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 Ferrlecit is sodium ferric gluconate complex. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ferrlecit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | Marketed (Rx) | AB | 1 | AB |
NDA 020955, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium ferric gluconate complex
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 078215 | AB (A-rated, therapeutically equivalent) | March 31, 2011 | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) |
Ferrlecit NDC codes
Questions
Is there a generic for Ferrlecit?
Yes. The generic name for Ferrlecit is sodium ferric gluconate complex. 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 Ferrlecit?
The active ingredient in Ferrlecit is sodium ferric gluconate complex, 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.