METHYLPHENIDATE HYDROCHLORIDE

Product NDC

47781-540

11-digit product format

477810540

Labeler code

47781

Product ID

47781-540_88dd19d0-ba88-38d9-5b83-3a159800df9c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

methylphenidate hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Alvogen Inc.

Application

ANDA204772

Marketing category

ANDA

Marketing start

2017-10-20

Marketing end

2020-02-01

Substance

METHYLPHENIDATE HYDROCHLORIDE

Active strength

10 mg/1

Pharmacologic classes

Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record