FDA Orange Book
Generic for Albenza
Albenza contains albendazole. 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 Albenza is albendazole. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Albenza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Discontinued | None | 6 | AB |
NDA 020666, held by IMPAX LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic albendazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 208979 | AB (A-rated, therapeutically equivalent) | December 14, 2018 | 200MG |
| EDENBRIDGE PHARMACEUTICALS LLC | 211117 | AB (A-rated, therapeutically equivalent) | May 14, 2019 | 200MG |
| ACTAVIS ELIZABETH LLC | 208094 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 200MG |
| MSN LABORATORIES PRIVATE LTD | 213435 | AB (A-rated, therapeutically equivalent) | January 21, 2021 | 200MG |
| DR REDDYS LABORATORIES LTD | 211034 | AB (A-rated, therapeutically equivalent) | January 26, 2021 | 200MG |
| ALEMBIC PHARMACEUTICALS LTD | 215652 | AB (A-rated, therapeutically equivalent) | September 4, 2024 | 200MG |
Albenza NDC codes
Questions
Is there a generic for Albenza?
Yes. The generic name for Albenza is albendazole. 6 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 Albenza?
The active ingredient in Albenza is albendazole, 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.