FDA Orange Book
Generic for Methylin
Methylin 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 Methylin is methylphenidate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Methylin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 10MG/5ML | Marketed (Rx) | AA | 8 | AA |
| solution, oral | 5MG/5ML | Marketed (Rx) | AA | 8 | AA |
| tablet, chewable, oral | 10MG | Discontinued | None | 2 | AB |
| tablet, chewable, oral | 2.5MG | Discontinued | None | 2 | AB |
| tablet, chewable, oral | 5MG | Discontinued | None | 2 | AB |
NDA 021419, 021475, held by SPECGX LLC. 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 |
|---|---|---|---|---|
| TRIS PHARMA INC | 091601 | AA (A-rated, therapeutically equivalent) | July 23, 2010 | 10MG/5ML, 5MG/5ML |
| NOVEL LABORATORIES INC | 204602 | AA (A-rated, therapeutically equivalent) | August 14, 2015 | 10MG/5ML, 5MG/5ML |
| RISING PHARMA HOLDINGS INC | 205756 | AB (A-rated, therapeutically equivalent) | November 7, 2016 | 10MG, 2.5MG, 5MG |
| ABHAI LLC | 207485 | AA (A-rated, therapeutically equivalent) | November 18, 2016 | 10MG/5ML, 5MG/5ML |
| ASCENT PHARMACEUTICALS INC | 210354 | AB (A-rated, therapeutically equivalent) | December 29, 2017 | 10MG, 2.5MG, 5MG |
| ADAPTIS PHARMA PRIVATE LTD | 210139 | AA (A-rated, therapeutically equivalent) | October 3, 2018 | 10MG/5ML, 5MG/5ML |
| ALKEM LABORATORIES LTD | 211647 | AA (A-rated, therapeutically equivalent) | March 30, 2020 | 10MG/5ML, 5MG/5ML |
| ANDA REPOSITORY LLC | 210764 | AA (A-rated, therapeutically equivalent) | April 10, 2020 | 10MG/5ML, 5MG/5ML |
| QUAGEN PHARMACEUTICALS LLC | 213567 | AA (A-rated, therapeutically equivalent) | June 4, 2020 | 10MG/5ML, 5MG/5ML |
| ASCENT PHARMACEUTICALS INC | 207417 | AA (A-rated, therapeutically equivalent) | January 29, 2021 | 10MG/5ML, 5MG/5ML |
Methylin NDC codes
Questions
Is there a generic for Methylin?
Yes. The generic name for Methylin is methylphenidate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Methylin?
The active ingredient in Methylin 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 Methylin and Methylphenidate
- What is Methylin used for?FDA label uses
- Is Methylin a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
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