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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA

DEXMETHYLPHENIDATE HYDROCHLORIDE | A201231 | SUN PHARMACEUTICAL INDUSTRIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FOCALIN(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$0.3397

per ea

Lowest NADAC/Unit

$0.1890

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
57664037988DEXMETHYLPHENIDATE 10 MG TAB	$0.3397	EA	Generic	—	2026-10-21
57664037888DEXMETHYLPHENIDATE 5 MG TAB	$0.2626	EA	Generic	—	2026-10-21
57664037688DEXMETHYLPHENIDATE 2.5 MG TAB	$0.1890	EA	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$24.55

Highest Price

$48.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
57664-0376-88DEXMETHYLPHENIDATE HCL 2.5MG TAB	$24.55	FSS	Golden State Medical Supply, Inc.	06/14/2028
57664-0378-88DEXMETHYLPHENIDATE HCL 5MG TAB	$37.13	FSS	Golden State Medical Supply, Inc.	06/14/2028
57664-0379-88DEXMETHYLPHENIDATE HCL 10MG TAB	$48.93	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED USA LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 132281998

LONZA INCDEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)

DMF 171172004

CURIA MISSOURI INCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 203852007

PURISYS LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 294112016

SPECGX LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 306572016

ALKEM LABORATORIES LTDDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 329022018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 24, 2015

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 24, 2015

#003 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 24, 2015