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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 076655

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NDA 076655 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-five 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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 076655

Tradename:	METHYLPHENIDATE HYDROCHLORIDE
Applicant:	Actavis Labs Fl
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 076655

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 076655

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076655	ANDA	Actavis Pharma, Inc.	62037-727	62037-727-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-727-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	54MG
Approval Date:	Mar 21, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	72MG
Approval Date:	Feb 28, 2022	TE:	AB	RLD:	No

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