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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 211647

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NDA 211647 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, 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 211647

Tradename:	METHYLPHENIDATE HYDROCHLORIDE
Applicant:	Alkem Labs Ltd
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 211647

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 211647

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	SOLUTION;ORAL	211647	ANDA	Ascend Laboratories, LLC	67877-602	67877-602-91	500 mL in 1 BOTTLE (67877-602-91)
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	SOLUTION;ORAL	211647	ANDA	Ascend Laboratories, LLC	67877-603	67877-603-91	500 mL in 1 BOTTLE (67877-603-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Mar 30, 2020	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/5ML
Approval Date:	Mar 30, 2020	TE:	AA	RLD:	No

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