FDA Orange Book
Generic for Adderall
Adderall contains dextroamphetamine and amphetamine. 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 Adderall is dextroamphetamine and amphetamine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Adderall products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1.25MG;1.25MG;1.25MG;1.25MG | Discontinued | None | 18 | AB |
| tablet, oral | 1.875MG;1.875MG;1.875MG;1.875MG | Discontinued | None | 16 | AB |
| tablet, oral | 2.5MG;2.5MG;2.5MG;2.5MG | Discontinued | None | 18 | AB |
| tablet, oral | 3.125MG;3.125MG;3.125MG;3.125MG | Discontinued | None | 15 | AB |
| tablet, oral | 3.75MG;3.75MG;3.75MG;3.75MG | Discontinued | None | 17 | AB |
| tablet, oral | 5MG;5MG;5MG;5MG | Discontinued | None | 18 | AB |
| tablet, oral | 7.5MG;7.5MG;7.5MG;7.5MG | Discontinued | None | 18 | AB |
NDA 011522, held by TEVA WOMENS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dextroamphetamine and amphetamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 040422 | AB (A-rated, therapeutically equivalent) | February 11, 2002 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| EPIC PHARMA LLC | 040444 | AB (A-rated, therapeutically equivalent) | June 19, 2002 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| SANDOZ INC | 040439 | AB (A-rated, therapeutically equivalent) | September 27, 2002 | 1.25MG;1.25MG;1.25MG;1.25MG, 2.5MG;2.5MG;2.5MG;2.5MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 040480 | AB (A-rated, therapeutically equivalent) | September 9, 2003 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| SPECGX LLC | 040440 | AB (A-rated, therapeutically equivalent) | October 7, 2003 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| AUROLIFE PHARMA LLC | 202424 | AB (A-rated, therapeutically equivalent) | November 27, 2013 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ACTAVIS ELIZABETH LLC | 206340 | AB (A-rated, therapeutically equivalent) | February 5, 2016 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ALVOGEN INC | 207388 | AB (A-rated, therapeutically equivalent) | July 28, 2017 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ZYDUS PHARMACEUTICALS USA INC | 207340 | AB (A-rated, therapeutically equivalent) | October 31, 2017 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| NUVO PHARMACEUTICAL INC | 209799 | AB (A-rated, therapeutically equivalent) | December 28, 2017 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ELITE LABORATORIES INC | 211352 | AB (A-rated, therapeutically equivalent) | December 7, 2018 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| PHARMOBEDIENT CONSULTING LLC | 210293 | AB (A-rated, therapeutically equivalent) | April 3, 2020 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| RHODES PHARMACEUTICALS LP | 213111 | AB (A-rated, therapeutically equivalent) | January 13, 2021 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ASCENT PHARMACEUTICALS INC | 213709 | AB (A-rated, therapeutically equivalent) | April 22, 2021 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| GRANULES PHARMACEUTICALS INC | 215771 | AB (A-rated, therapeutically equivalent) | December 28, 2021 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| CEDIPROF INC | 210754 | AB (A-rated, therapeutically equivalent) | July 5, 2022 | 1.25MG;1.25MG;1.25MG;1.25MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| LANNETT CO INC | 215565 | AB (A-rated, therapeutically equivalent) | July 8, 2022 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ALKEM LABORATORIES LTD | 217787 | AB (A-rated, therapeutically equivalent) | October 6, 2023 | 1.25MG;1.25MG;1.25MG;1.25MG, 1.875MG;1.875MG;1.875MG;1.875MG, 2.5MG;2.5MG;2.5MG;2.5MG, 3.125MG;3.125MG;3.125MG;3.125MG, 3.75MG;3.75MG;3.75MG;3.75MG, 5MG;5MG;5MG;5MG, 7.5MG;7.5MG;7.5MG;7.5MG |
Questions
Is there a generic for Adderall?
Yes. The generic name for Adderall is dextroamphetamine and amphetamine. 18 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 Adderall?
The active ingredient in Adderall is dextroamphetamine and amphetamine, 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.
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