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METHYLPHENIDATE HYDROCHLORIDE

ANDA

METHYLPHENIDATE HYDROCHLORIDE | A205327 | OSMOTICA PHARMACEUTICAL US LLC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CONCERTA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$16.74

per ea

Lowest NADAC/Unit

$0.5758

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
13811071030METHYLPHENIDATE ER 72 MG TAB	$16.74	EA	Generic	—	2026-08-19
13811070910METHYLPHENIDATE ER 54 MG TAB	$0.8092	EA	Generic	—	2026-08-19
13811070810METHYLPHENIDATE ER 36 MG TAB	$0.6665	EA	Generic	—	2026-08-19
13811070710METHYLPHENIDATE ER 27 MG TAB	$0.6446	EA	Generic	—	2026-08-19
13811070610METHYLPHENIDATE ER 18 MG TAB	$0.5758	EA	Generic	—	2026-08-19

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

API Supply Chain12 active DMFs6 inactive

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

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 101371993

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 127691997

CHATTEM CHEMICALS INCMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 163312002

CAMBREX CHARLES CITY INCMETHYLPHENIDATE HYDROCHLORIDE (RITALIN HCL)

DMF 166102003

CURIA MISSOURI INCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 190632005

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 195472006

NORAMCO LLCMETHYLPHENIDATE HYDROCHLORIDE

DMF 222442008

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP (NP)

DMF 257762013

JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I)

DMF 305102016

JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II)

DMF 305462021

ALKEM LABORATORIES LTDMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 306822016

SIEGFRIED USA LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 342742019

UCB INCInactiveMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 116351995

SIEGFRIED USA LLCInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 129891998

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETHYLPHENIDATE HYDROCHLORIDE

DMF 154852001

IPCA LABORATORIES LTDInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 206212007

MACFARLAN SMITH LTDInactiveMETHYLPHENIDATE HYDROCHLORIDE

DMF 305792016

CODY LABORATORIES INCInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 335092019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 2, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.