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METHYLPHENIDATE HYDROCHLORIDE

ANDA

METHYLPHENIDATE HYDROCHLORIDE | A202608 | SPECGX LLC

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$0.8092

per ea

Lowest NADAC/Unit

$0.6446

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00406015401METHYLPHENIDATE ER 54 MG TAB	$0.8092	EA	Generic	—	2026-08-19
00406013601METHYLPHENIDATE ER 36 MG TAB	$0.6665	EA	Generic	—	2026-08-19
00406012701METHYLPHENIDATE ER 27 MG TAB	$0.6446	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 | 3 NDCs (3 FSS)

Lowest Price

$150.75

Highest Price

$185.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00406-0127-01METHYLPHENIDATE HCL 27MG TAB,SA	$177.40	FSS	SpecGx LLC	09/14/2027
00406-0136-01METHYLPHENIDATE HCL 36MG TAB,SA	$185.43	FSS	SpecGx LLC	09/14/2027
00406-0154-01METHYLPHENIDATE HCL 54MG TAB,SA	$150.75	FSS	SpecGx LLC	09/14/2027

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
Jan 3, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 27MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 28, 2012

No patent or exclusivity listings for this strength.

#002 — 36MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 28, 2012

#003 — 54MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 28, 2012