FDA Orange Book
Generic for Strattera
Strattera contains atomoxetine. 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 Strattera is atomoxetine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Strattera products the Orange Book lists.
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Strattera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Discontinued | None | 9 | AB |
| capsule, oral | EQ 10MG BASE | Discontinued | None | 9 | AB |
| capsule, oral | EQ 18MG BASE | Discontinued | None | 9 | AB |
| capsule, oral | EQ 25MG BASE | Discontinued | None | 9 | AB |
| capsule, oral | EQ 40MG BASE | Discontinued | None | 9 | AB |
| capsule, oral | EQ 5MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 60MG BASE | Discontinued | None | 9 | AB |
| capsule, oral | EQ 80MG BASE | Discontinued | None | 9 | AB |
NDA 021411, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic atomoxetine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 079017 | AB (A-rated, therapeutically equivalent) | September 16, 2010 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| APOTEX INC | 078983 | AB (A-rated, therapeutically equivalent) | May 30, 2017 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| AUROBINDO PHARMA LTD | 079016 | AB (A-rated, therapeutically equivalent) | May 30, 2017 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 079019 | AB (A-rated, therapeutically equivalent) | May 30, 2017 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| TEVA PHARMACEUTICALS USA | 079022 | AB (A-rated, therapeutically equivalent) | May 30, 2017 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| DR REDDYS LABORATORIES LTD | 090609 | AB (A-rated, therapeutically equivalent) | February 23, 2018 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| STRIDES PHARMA GLOBAL PTE LTD | 079021 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| HETERO LABS LTD UNIT V | 202682 | AB (A-rated, therapeutically equivalent) | March 11, 2021 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
| PHARMAZONE | 218875 | AB (A-rated, therapeutically equivalent) | June 16, 2026 | EQ 100MG BASE, EQ 10MG BASE, EQ 18MG BASE, EQ 25MG BASE, EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE |
Strattera NDC codes
Questions
Is there a generic for Strattera?
Yes. The generic name for Strattera is atomoxetine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Strattera products the Orange Book lists.
What is the generic name for Strattera?
The active ingredient in Strattera is atomoxetine, 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.