FDA Orange Book
Generic for Wellcovorin
Wellcovorin contains leucovorin. 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 Wellcovorin is leucovorin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Wellcovorin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 25MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 5 | AB |
NDA 018342, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic leucovorin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR PHARMACEUTICALS | 071199 | AB (A-rated, therapeutically equivalent) | September 24, 1987 | EQ 25MG BASE |
| BARR PHARMACEUTICALS | 071198 | AB (A-rated, therapeutically equivalent) | September 24, 1987 | EQ 5MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 072736 | AB (A-rated, therapeutically equivalent) | February 22, 1993 | EQ 25MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 072733 | AB (A-rated, therapeutically equivalent) | February 22, 1993 | EQ 5MG BASE |
| EPIC PHARMA LLC | 074544 | AB (A-rated, therapeutically equivalent) | August 28, 1997 | EQ 25MG BASE, EQ 5MG BASE |
| INGENUS PHARMACEUTICALS LLC | 211132 | AB (A-rated, therapeutically equivalent) | July 30, 2020 | EQ 25MG BASE, EQ 5MG BASE |
| LEADING PHARMA LLC | 213929 | AB (A-rated, therapeutically equivalent) | October 22, 2020 | EQ 25MG BASE, EQ 5MG BASE |
Questions
Is there a generic for Wellcovorin?
Yes. The generic name for Wellcovorin is leucovorin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Wellcovorin?
The active ingredient in Wellcovorin is leucovorin, 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.