Is there a generic for Dexmethylphenidate hydrochloride?

Yes. The FDA Orange Book lists 21 approved generic (ANDA) applications for Dexmethylphenidate hydrochloride, referencing the brand FOCALIN XR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dexmethylphenidate hydrochloride?

FOCALIN XR (NDA 021802, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dexmethylphenidate hydrochloride are approved?

Dexmethylphenidate hydrochloride is approved in the following dosage forms: capsule, extended release, tablet.

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)

Generics (ANDA)

Listed patents

Presentations

108

Originator applications

Brand (NDA) products

FOCALIN XRRLD

SANDOZNDA 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

FOCALINRLD

SANDOZNDA 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

Abbreviated applications

Generic (ANDA) products (21)

DEXMETHYLPHENIDATE HYDROCHLORIDE

ASCENT 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 HYDROCHLORIDE

PLATINUMANDA 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 HYDROCHLORIDE

SUN 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 HYDROCHLORIDE

GRANULESANDA 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 HYDROCHLORIDE

BIONPHARMAANDA 20975420202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

DEXMETHYLPHENIDATE HYDROCHLORIDE

ALKEM 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 HYDROCHLORIDE

ADARE 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 HYDROCHLORIDE

CEDIPROF 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 HYDROCHLORIDE

RHODES 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 HYDROCHLORIDE

LANNETT 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 HYDROCHLORIDE

IMPAX 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 HYDROCHLORIDE

TEVA 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 HYDROCHLORIDE

PH 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 HYDROCHLORIDE

TRIS 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 HYDROCHLORIDE

ABHAI 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 HYDROCHLORIDE

NOVEL 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 HYDROCHLORIDE

SUN 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 HYDROCHLORIDE

AUROLIFE 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 HYDROCHLORIDE

IMPAX 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 HYDROCHLORIDE

TEVA 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 HYDROCHLORIDE

TEVA 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	—

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Nov 13, 2001

25 yr ago

Most recent approval

Dec 08, 2021

4 yr 8 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.

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