FDA Orange Book
Generic for Aptensio XR
Aptensio XR contains methylphenidate. 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 Aptensio XR is methylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
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Aptensio 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) | AB3 | 6 | AB2, AB1, AB3 |
| capsule, extended release, oral | 15MG | Marketed (Rx) | AB3 | 1 | AB3 |
| capsule, extended release, oral | 20MG | Marketed (Rx) | AB3 | 6 | AB1, AB2, AB3 |
| capsule, extended release, oral | 30MG | Marketed (Rx) | AB3 | 6 | AB1, AB2, AB3 |
| capsule, extended release, oral | 40MG | Marketed (Rx) | AB3 | 5 | AB1, AB2, AB3 |
| capsule, extended release, oral | 50MG | Marketed (Rx) | AB3 | 3 | AB2, AB3 |
| capsule, extended release, oral | 60MG | Marketed (Rx) | AB3 | 5 | AB2, AB1, AB3 |
NDA 205831, held by RHODES PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methylphenidate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 078458 | AB1 (A-rated, therapeutically equivalent) | December 1, 2011 | 20MG, 30MG, 40MG, 60MG |
| TEVA PHARMACEUTICALS USA | 077707 | AB2 (A-rated, therapeutically equivalent) | July 19, 2012 | 10MG, 20MG, 30MG |
| SPECGX LLC | 203583 | AB2 (A-rated, therapeutically equivalent) | September 29, 2015 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| IMPAX LABORATORIES INC | 205105 | AB2 (A-rated, therapeutically equivalent) | July 28, 2016 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| DR REDDYS LABORATORIES SA | 200886 | AB1 (A-rated, therapeutically equivalent) | February 26, 2018 | 10MG |
| ACTAVIS ELIZABETH LLC | 208861 | AB3 (A-rated, therapeutically equivalent) | December 13, 2018 | 10MG, 15MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| GRANULES PHARMACEUTICALS INC | 211796 | AB1 (A-rated, therapeutically equivalent) | May 23, 2019 | 10MG, 20MG, 30MG, 40MG, 60MG |
Aptensio XR NDC codes
Questions
Is there a generic for Aptensio XR?
Yes. The generic name for Aptensio XR is methylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
What is the generic name for Aptensio XR?
The active ingredient in Aptensio XR is methylphenidate, 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.