Metadate CD

Product NDC

53014-582

11-digit product format

530140582

Labeler code

53014

Product ID

53014-582_bb9a02a4-3803-482d-970d-0f27f3b6f452

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

methylphenidate hydrochloride

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Unither Manufacturing, LLC

Application

NDA021259

Marketing category

NDA

Marketing start

2006-03-21

Marketing end

0000-00-00

Substance

METHYLPHENIDATE HYDROCHLORIDE

Active strength

40 mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record