FDA Orange Book
Generic for Gleostine
Gleostine contains lomustine. 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 Gleostine is lomustine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Gleostine products the Orange Book lists.
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Gleostine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 1 | AB |
| capsule, oral | 10MG | Marketed (Rx) | AB | 1 | AB |
| capsule, oral | 40MG | Marketed (Rx) | AB | 1 | AB |
| capsule, oral | 5MG | Discontinued | None | 0 | None |
NDA 017588, 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 lomustine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CARNEGIE PHARMACEUTICALS LLC | 219265 | AB (A-rated, therapeutically equivalent) | October 27, 2025 | 100MG, 10MG, 40MG |
Gleostine NDC codes
Questions
Is there a generic for Gleostine?
Yes. The generic name for Gleostine is lomustine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Gleostine products the Orange Book lists.
What is the generic name for Gleostine?
The active ingredient in Gleostine is lomustine, 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.