FDA Orange Book
Generic for Arimidex
Arimidex contains anastrozole. 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 Arimidex is anastrozole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Arimidex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | AB | 8 | AB |
NDA 020541, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic anastrozole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 090568 | AB (A-rated, therapeutically equivalent) | June 28, 2010 | 1MG |
| CIPLA LTD | 091164 | AB (A-rated, therapeutically equivalent) | June 28, 2010 | 1MG |
| KENTON CHEMICALS AND PHARMACEUTICALS CORP | 078944 | AB (A-rated, therapeutically equivalent) | June 28, 2010 | 1MG |
| NATCO PHARMA LTD | 079220 | AB (A-rated, therapeutically equivalent) | June 28, 2010 | 1MG |
| TEVA PHARMACEUTICALS USA | 078058 | AB (A-rated, therapeutically equivalent) | June 28, 2010 | 1MG |
| ZYDUS PHARMACEUTICALS USA INC | 078921 | AB (A-rated, therapeutically equivalent) | June 28, 2010 | 1MG |
| PHARMOBEDIENT CONSULTING LLC | 206037 | AB (A-rated, therapeutically equivalent) | November 9, 2018 | 1MG |
| EUGIA PHARMA SPECIALITIES LTD | 212434 | AB (A-rated, therapeutically equivalent) | July 24, 2020 | 1MG |
Arimidex NDC codes
Questions
Is there a generic for Arimidex?
Yes. The generic name for Arimidex is anastrozole. 8 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 Arimidex?
The active ingredient in Arimidex is anastrozole, 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.