FDA Orange Book
Generic for Adderall XR
Adderall XR 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 XR is dextroamphetamine and amphetamine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Adderall XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 1.25MG;1.25MG;1.25MG;1.25MG | Marketed (Rx) | AB1 | 10 | AB1 |
| capsule, extended release, oral | 2.5MG;2.5MG;2.5MG;2.5MG | Marketed (Rx) | AB1 | 10 | AB1 |
| capsule, extended release, oral | 3.75MG;3.75MG;3.75MG;3.75MG | Marketed (Rx) | AB1 | 10 | AB1 |
| capsule, extended release, oral | 5MG;5MG;5MG;5MG | Marketed (Rx) | AB1 | 10 | AB1 |
| capsule, extended release, oral | 6.25MG;6.25MG;6.25MG;6.25MG | Marketed (Rx) | AB1 | 13 | AB1, AB2 |
| capsule, extended release, oral | 7.5MG;7.5MG;7.5MG;7.5MG | Marketed (Rx) | AB1 | 10 | AB1 |
NDA 021303, held by TAKEDA PHARMACEUTICALS USA 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 |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 077302 | AB1 (A-rated, therapeutically equivalent) | June 22, 2012 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| IMPAX LABORATORIES INC | 076852 | AB1 (A-rated, therapeutically equivalent) | February 16, 2016 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ANI PHARMACEUTICALS INC | 205401 | AB1 (A-rated, therapeutically equivalent) | January 22, 2019 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| SPECGX LLC | 211547 | AB1 (A-rated, therapeutically equivalent) | April 22, 2019 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| RHODES PHARMACEUTICALS LP | 210651 | AB1 (A-rated, therapeutically equivalent) | May 17, 2019 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ELITE LABORATORIES INC | 212037 | AB1 (A-rated, therapeutically equivalent) | December 11, 2019 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| ASCENT PHARMACEUTICALS INC | 214959 | AB1 (A-rated, therapeutically equivalent) | September 29, 2021 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| LANNETT CO INC | 214403 | AB1 (A-rated, therapeutically equivalent) | November 26, 2021 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| TEVA PHARMACEUTICALS USA INC | 210876 | AB2 (A-rated, therapeutically equivalent) | January 31, 2022 | 6.25MG;6.25MG;6.25MG;6.25MG |
| GRANULES PHARMACEUTICALS INC | 217027 | AB1 (A-rated, therapeutically equivalent) | January 23, 2023 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
| SPECGX LLC | 211546 | AB2 (A-rated, therapeutically equivalent) | August 31, 2023 | 6.25MG;6.25MG;6.25MG;6.25MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 215997 | AB2 (A-rated, therapeutically equivalent) | September 27, 2023 | 6.25MG;6.25MG;6.25MG;6.25MG |
| LUPIN INC | 214777 | AB1 (A-rated, therapeutically equivalent) | November 7, 2024 | 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, 6.25MG;6.25MG;6.25MG;6.25MG, 7.5MG;7.5MG;7.5MG;7.5MG |
Adderall XR NDC codes
Questions
Is there a generic for Adderall XR?
Yes. The generic name for Adderall XR is dextroamphetamine and amphetamine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Adderall XR?
The active ingredient in Adderall XR 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.