FDA Orange Book
Generic for Ritalin
Ritalin 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 Ritalin is methylphenidate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ritalin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 12 | AB |
NDA 010187, 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 methylphenidate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SPECGX LLC | 040300 | AB (A-rated, therapeutically equivalent) | November 27, 1998 | 10MG, 20MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 090710 | AB (A-rated, therapeutically equivalent) | March 15, 2012 | 10MG, 20MG, 5MG |
| OXFORD PHARMACEUTICALS LLC | 202892 | AB (A-rated, therapeutically equivalent) | September 23, 2014 | 10MG, 20MG, 5MG |
| ASCENT PHARMACEUTICALS INC | 207416 | AB (A-rated, therapeutically equivalent) | September 22, 2015 | 10MG, 20MG, 5MG |
| NOVEL LABORATORIES INC | 207884 | AB (A-rated, therapeutically equivalent) | November 13, 2015 | 10MG, 20MG, 5MG |
| MPP PHARMA LLC | 207587 | AB (A-rated, therapeutically equivalent) | March 3, 2017 | 10MG, 20MG, 5MG |
| ABHAI LLC | 206932 | AB (A-rated, therapeutically equivalent) | May 11, 2017 | 10MG, 20MG, 5MG |
| BIONPHARMA INC | 209753 | AB (A-rated, therapeutically equivalent) | March 2, 2018 | 10MG, 20MG, 5MG |
| CEDIPROF INC | 208737 | AB (A-rated, therapeutically equivalent) | February 1, 2019 | 10MG, 20MG, 5MG |
| ALKEM LABORATORIES LTD | 211779 | AB (A-rated, therapeutically equivalent) | October 4, 2019 | 10MG, 20MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 212697 | AB (A-rated, therapeutically equivalent) | July 23, 2020 | 10MG, 20MG, 5MG |
| ACCORD HEALTHCARE INC | 213936 | AB (A-rated, therapeutically equivalent) | October 28, 2020 | 10MG, 20MG, 5MG |
Ritalin NDC codes
Questions
Is there a generic for Ritalin?
Yes. The generic name for Ritalin is methylphenidate. 12 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 Ritalin?
The active ingredient in Ritalin 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 Ritalin and Methylphenidate
- What is Ritalin used for?FDA label uses
- Is Ritalin a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
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