FDA Orange Book
Generic for Fusilev
Fusilev contains levoleucovorin. 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 Fusilev is levoleucovorin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Fusilev products the Orange Book lists.
Run it in Rivvi
Map Fusilev and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Fusilev products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 50MG BASE/VIAL | Discontinued | None | 0 | None |
| solution, intravenous | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | Discontinued | None | 4 | AP |
| solution, intravenous | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | Discontinued | None | 2 | AP |
NDA 020140, held by ACROTECH BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levoleucovorin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 203563 | AP (A-rated, therapeutically equivalent) | March 9, 2015 | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) |
| GLAND PHARMA LTD | 210892 | AP (A-rated, therapeutically equivalent) | September 14, 2018 | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML), EQ 250MG BASE/25ML (EQ 10MG BASE/ML) |
| MEITHEAL PHARMACEUTICALS INC | 211002 | AP (A-rated, therapeutically equivalent) | August 16, 2019 | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) |
| HAINAN POLY PHARMACEUTICAL CO LTD | 217314 | AP (A-rated, therapeutically equivalent) | May 22, 2023 | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML), EQ 250MG BASE/25ML (EQ 10MG BASE/ML) |
Questions
Is there a generic for Fusilev?
Yes. The generic name for Fusilev is levoleucovorin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Fusilev products the Orange Book lists.
What is the generic name for Fusilev?
The active ingredient in Fusilev is levoleucovorin, 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.