FDA Orange Book
Generic for Stromectol
Stromectol contains ivermectin. 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 Stromectol is ivermectin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Stromectol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 6MG | Discontinued | None | 1 | None |
NDA 050742, held by MERCK SHARP AND DOHME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ivermectin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EDENBRIDGE PHARMACEUTICALS LLC | 204154 | AB (A-rated, therapeutically equivalent) | October 24, 2014 | 3MG |
| PHARMAZONE | 218324 | AB (A-rated, therapeutically equivalent) | October 16, 2024 | 3MG |
| RUBICON RESEARCH LTD | 215922 | AB (A-rated, therapeutically equivalent) | January 22, 2025 | 3MG, 6MG |
| EPIC PHARMA LLC | 218805 | AB (A-rated, therapeutically equivalent) | September 9, 2025 | 3MG |
| ZYDUS LIFESCIENCES LTD | 216863 | AB (A-rated, therapeutically equivalent) | February 26, 2026 | 3MG |
| E5 PHARMA LLC | 216808 | AB (A-rated, therapeutically equivalent) | March 9, 2026 | 3MG |
| AJANTA PHARMA LTD | 218509 | AB (A-rated, therapeutically equivalent) | April 7, 2026 | 3MG |
Stromectol NDC codes
Questions
Is there a generic for Stromectol?
Yes. The generic name for Stromectol is ivermectin. 7 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 Stromectol?
The active ingredient in Stromectol is ivermectin, 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.