Modafinil

Product NDC

42291-599

11-digit product format

422910599

Labeler code

42291

Product ID

42291-599_862ec4da-cc74-e098-e053-2a91aa0aa3c8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Modafinil

Dosage form

TABLET

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA076715

Marketing category

ANDA

Marketing start

2013-04-03

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record