Modafinil

Product NDC

0143-9968

11-digit product format

001439968

Labeler code

0143

Product ID

0143-9968_6f5772d6-9158-4447-9577-54b7cdf6ea2a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

modafinil

Dosage form

TABLET

Route

ORAL

Labeler

Hikma Pharmaceuticals USA Inc.

Application

ANDA090543

Marketing category

ANDA

Marketing start

2012-09-26

Marketing end

2020-08-23

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