Modafinil

Product NDC

51079-561

11-digit product format

510790561

Labeler code

51079

Product ID

51079-561_96c2ee5a-0754-7774-e053-2995a90ad6fc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

modafinil

Dosage form

TABLET

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA076594

Marketing category

ANDA

Marketing start

2012-09-06

Marketing end

2020-08-31

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