FDA Orange Book
Generic for Focalin XR
Focalin XR contains dexmethylphenidate. 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 Focalin XR is dexmethylphenidate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Focalin XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 10MG | Marketed (Rx) | AB | 7 | AB |
| capsule, extended release, oral | 15MG | Marketed (Rx) | AB | 7 | AB |
| capsule, extended release, oral | 20MG | Marketed (Rx) | AB | 7 | AB |
| capsule, extended release, oral | 25MG | Marketed (Rx) | AB | 6 | AB |
| capsule, extended release, oral | 30MG | Marketed (Rx) | AB | 7 | AB |
| capsule, extended release, oral | 35MG | Marketed (Rx) | AB | 6 | AB |
| capsule, extended release, oral | 40MG | Marketed (Rx) | AB | 6 | AB |
| capsule, extended release, oral | 5MG | Marketed (Rx) | AB | 7 | AB |
NDA 021802, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dexmethylphenidate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 078908 | AB (A-rated, therapeutically equivalent) | November 19, 2013 | 10MG, 15MG, 20MG, 5MG |
| IMPAX LABORATORIES INC | 079108 | AB (A-rated, therapeutically equivalent) | August 5, 2015 | 10MG, 15MG, 20MG, 30MG, 5MG |
| PH HEALTH LTD | 202842 | AB (A-rated, therapeutically equivalent) | November 30, 2016 | 10MG, 15MG, 20MG, 25MG, 30MG, 35MG, 40MG, 5MG |
| IMPAX LABORATORIES INC | 203614 | AB (A-rated, therapeutically equivalent) | July 5, 2017 | 25MG, 35MG |
| TEVA PHARMACEUTICALS USA | 202731 | AB (A-rated, therapeutically equivalent) | July 5, 2017 | 25MG, 30MG, 35MG, 40MG |
| ADARE PHARMACEUTICALS INC | 210279 | AB (A-rated, therapeutically equivalent) | October 9, 2018 | 10MG, 15MG, 20MG, 25MG, 30MG, 35MG, 40MG, 5MG |
| GRANULES PHARMACEUTICALS INC | 213813 | AB (A-rated, therapeutically equivalent) | September 9, 2020 | 10MG, 15MG, 20MG, 25MG, 30MG, 35MG, 40MG, 5MG |
| PLATINUM PHARMACEUTICALS | 078992 | AB (A-rated, therapeutically equivalent) | November 23, 2021 | 10MG, 15MG, 20MG, 30MG, 40MG, 5MG |
| ASCENT PHARMACEUTICALS INC | 215523 | AB (A-rated, therapeutically equivalent) | December 8, 2021 | 10MG, 15MG, 20MG, 25MG, 30MG, 35MG, 40MG, 5MG |
Focalin XR NDC codes
Questions
Is there a generic for Focalin XR?
Yes. The generic name for Focalin XR is dexmethylphenidate. 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 Focalin XR?
The active ingredient in Focalin XR is dexmethylphenidate, 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.