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METHYLPHENIDATE HYDROCHLORIDE

ANDA

METHYLPHENIDATE HYDROCHLORIDE | A207416 | ASCENT PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: RITALIN(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$0.2102

per ea

Lowest NADAC/Unit

$0.1309

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
31722017501METHYLPHENIDATE 20 MG TABLET	$0.2102	EA	Generic	—	2026-08-19
50268052915METHYLPHENIDATE 20 MG TABLET	$0.2102	EA	Generic	—	2026-08-19
31722017401METHYLPHENIDATE 10 MG TABLET	$0.1668	EA	Generic	—	2026-08-19
31722017301METHYLPHENIDATE 5 MG TABLET	$0.1309	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$18.81

Highest Price

$38.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72865-0122-01METHYLPHENIDATE HCL 5MG TAB	$38.99	FSS	XLCare Pharmaceuticals, Inc.	05/31/2026
72865-0123-01METHYLPHENIDATE HCL 10MG TAB	$22.75	FSS	XLCare Pharmaceuticals, Inc.	05/31/2026
72865-0124-01METHYLPHENIDATE HCL 20MG TAB	$21.50	FSS	XLCare Pharmaceuticals, Inc.	05/31/2026
31722-0173-01METHYLPHENIDATE HCL 5MG TAB	$18.81	FSS	AvKare, LLC	06/14/2028
31722-0174-01METHYLPHENIDATE HCL 10MG TAB	$26.81	FSS	AvKare, LLC	06/14/2028
31722-0175-01METHYLPHENIDATE HCL 20MG TAB	$38.00	FSS	AvKare, LLC	06/14/2028

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

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
Sep 24, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 22, 2015

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 22, 2015

#003 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 22, 2015