Modafinil

Product NDC

50742-153

11-digit product format

507420153

Labeler code

50742

Product ID

50742-153_603ee70b-3373-48d8-9afb-8f0e66bf550b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Modafinil

Dosage form

TABLET

Route

ORAL

Labeler

Ingenus Pharmaceuticals, LLC

Application

ANDA078963

Marketing category

ANDA

Marketing start

2014-04-01

Marketing end

2020-01-31

Substance

MODAFINIL

Active strength

200 mg/1

Pharmacologic classes

Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]

DEA schedule

CIV

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record