Modafinil

Product NDC

49884-534

11-digit product format

498840534

Labeler code

49884

Product ID

49884-534_2a0cf156-42e6-4829-8f2c-5fe0fcd3858a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Modafinil

Dosage form

TABLET

Route

ORAL

Labeler

Par Pharmaceutical Inc.

Application

NDA020717

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2012-04-06

Marketing end

2020-12-31

Substance

MODAFINIL

Active strength

100 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