FDA Orange Book · active-ingredient family
Dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride: 2 brands, 21 generics; first approved Nov 13, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
21
Listed patents
0
Presentations
108
Brand (NDA) products
Originator applications
- FOCALIN XRRLDSANDOZNDA 02180220058 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - FOCALINRLDSANDOZNDA 02127820013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Generic (ANDA) products (21)
Abbreviated applications
- DEXMETHYLPHENIDATE HYDROCHLORIDEASCENT PHARMS INCANDA 21552320218 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDEPLATINUMANDA 07899220216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDESUN PHARM INDS INCANDA 20673420218 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 20MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 25MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 30MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 35MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 40MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXMETHYLPHENIDATE HYDROCHLORIDEGRANULESANDA 21381320208 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDEBIONPHARMAANDA 20975420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXMETHYLPHENIDATE HYDROCHLORIDEALKEM LABS LTDANDA 21263120193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDEADARE PHARMS INCANDA 21027920188 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDECEDIPROF INCANDA 20921120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDERHODES PHARMSANDA 20875620173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXMETHYLPHENIDATE HYDROCHLORIDELANNETT CO INCANDA 20946820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DEXMETHYLPHENIDATE HYDROCHLORIDEIMPAX LABS INCANDA 20361420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS USAANDA 20273120174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDEPH HEALTHANDA 20284220168 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 25MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 35MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDETRIS PHARMA INCANDA 20790120163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDEABHAI LLCANDA 20693120153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDENOVEL LABS INCANDA 20453420153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 20123120153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDEAUROLIFE PHARMA LLCANDA 20258020158 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 5MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 10MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 20MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 25MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 35MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 40MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DEXMETHYLPHENIDATE HYDROCHLORIDEIMPAX LABS INCANDA 07910820155 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMS USAANDA 07890820134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 15MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - DEXMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMSANDA 07710720073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
25 yr 3 mo ago
Most recent approval
4 yr 11 mo ago
Approvals span 2001–2021 across 23 FDA applications.
Brand (NDA) 29%
Generic (ANDA) 2191%
Dexmethylphenidate hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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