Modafinil

Basic Information

Product Name

Modafinil

FDA Product Code

62332-385

Regulatory Information

NDC Product Code

62332-385

Application Number

ANDA202700

Marketing Category

C73584

Effective Date

October 1, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MODAFINIL

Quantity: 100 mg in 1 1

Code: R3UK8X3U3D

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

Code: R3UK8X3U3D

Modafinil

Basic Information

Regulatory Information

Company Information

Active Ingredients

POVIDONE, UNSPECIFIED

LACTOSE MONOHYDRATE

MICROCRYSTALLINE CELLULOSE

CROSPOVIDONE

MANNITOL

MAGNESIUM STEARATE

Active Moieties

MODAFINIL