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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091159

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NDA 091159 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Chartwell Molecular, Hibrow Hlthcare, Novel Labs Inc, Novitium Pharma, Quagen, Tris Pharma Inc, Rising, Strides Pharma, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma Intl, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Mpp Pharma, Oxford Pharms, and Prinston Inc, and is included in sixty-nine NDAs. It is available from thirty-six suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 091159

Tradename:	METHYLPHENIDATE HYDROCHLORIDE
Applicant:	Mountain
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 091159

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 091159

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	091159	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1800	0115-1800-01	100 TABLET in 1 BOTTLE, PLASTIC (0115-1800-01)
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	091159	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1801	0115-1801-01	100 TABLET in 1 BOTTLE, PLASTIC (0115-1801-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 12, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 12, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Mar 12, 2014	TE:	AB	RLD:	No

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