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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA

DEXMETHYLPHENIDATE HYDROCHLORIDE | A202842 | PH HEALTH LTD

8 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FOCALIN XR(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$2.04

per ea

Lowest NADAC/Unit

$0.9658

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49884033901DEXMETHYLPHENIDATE ER 35 MG CP	$2.04	EA	Generic	—	2026-06-17
49884024801DEXMETHYLPHENIDATE ER 20 MG CP	$2.03	EA	Generic	—	2026-06-17
49884033301DEXMETHYLPHENIDATE ER 25 MG CP	$1.99	EA	Generic	—	2026-06-17
49884054601DEXMETHYLPHENIDATE ER 40 MG CP	$1.93	EA	Generic	—	2026-06-10
49884004901DEXMETHYLPHENIDATE ER 10 MG CP	$1.56	EA	Generic	—	2026-06-17
49884004801DEXMETHYLPHENIDATE ER 5 MG CAP	$0.9658	EA	Generic	—	2026-06-17

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

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
Dec 6, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.