FDA Orange Book
Generic for Concerta
Concerta 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 Concerta is methylphenidate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Concerta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 18MG | Marketed (Rx) | AB | 8 | BX, AB |
| tablet, extended release, oral | 27MG | Marketed (Rx) | AB | 8 | BX, AB |
| tablet, extended release, oral | 36MG | Marketed (Rx) | AB | 8 | BX, AB |
| tablet, extended release, oral | 54MG | Marketed (Rx) | AB | 8 | BX, AB |
NDA 021121, held by JANSSEN PHARMACEUTICALS INC. 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 |
|---|---|---|---|---|
| LANNETT CO INC | 091695 | BX (B-rated, not considered equivalent) | July 9, 2013 | 18MG, 27MG, 36MG, 54MG |
| AUROLIFE PHARMA LLC | 206726 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 18MG, 27MG, 36MG, 54MG |
| OSMOTICA PHARMACEUTICAL US LLC | 205327 | AB (A-rated, therapeutically equivalent) | July 28, 2017 | 18MG, 27MG, 36MG, 54MG |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 076655 | AB (A-rated, therapeutically equivalent) | March 21, 2018 | 54MG |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 076772 | AB (A-rated, therapeutically equivalent) | March 22, 2018 | 18MG, 27MG, 36MG |
| ANDOR PHARMACEUTICALS LLC | 211918 | AB (A-rated, therapeutically equivalent) | April 24, 2019 | 18MG, 27MG, 36MG, 54MG |
| ASCENT PHARMACEUTICALS INC | 211009 | AB (A-rated, therapeutically equivalent) | September 3, 2019 | 18MG, 27MG, 36MG, 54MG |
| GRANULES PHARMACEUTICALS INC | 213473 | AB (A-rated, therapeutically equivalent) | July 29, 2020 | 18MG, 27MG, 36MG, 54MG |
| ALKEM LABORATORIES LTD | 214447 | AB (A-rated, therapeutically equivalent) | May 23, 2023 | 18MG, 27MG, 36MG, 54MG |
Concerta NDC codes
Questions
Is there a generic for Concerta?
Yes. The generic name for Concerta is methylphenidate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Concerta?
The active ingredient in Concerta 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.
More on Concerta and Methylphenidate
- What is Concerta used for?FDA label uses
- Is Concerta a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
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