FDA Orange Book
Generic for Ritalin-sr
Ritalin-sr 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-sr is methylphenidate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ritalin-sr products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 20MG | Discontinued | None | 4 | AB |
NDA 018029, held by NOVARTIS PHARMACEUTICALS CORP. 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 | 075629 | AB (A-rated, therapeutically equivalent) | May 9, 2000 | 20MG |
| ABHAI LLC | 207488 | AB (A-rated, therapeutically equivalent) | June 9, 2015 | 20MG |
| GRANULES PHARMACEUTICALS INC | 210992 | AB (A-rated, therapeutically equivalent) | November 21, 2018 | 20MG |
| ALKEM LABORATORIES LTD | 212288 | AB (A-rated, therapeutically equivalent) | October 6, 2020 | 20MG |
Questions
Is there a generic for Ritalin-sr?
Yes. The generic name for Ritalin-sr is methylphenidate. 4 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-sr?
The active ingredient in Ritalin-sr 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.