FDA Product

Nuvigil

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Nuvigil

FDA Product Code

42254-014

Regulatory Information

NDC Product Code

42254-014

Application Number

NDA021875

Marketing Category

C73594

Effective Date

February 8, 2010

Territorial Authority

USA

FDA Title

NUVIGIL (armodafinil) Tablets [C-IV]

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerRebel Distributors Corp

DUNS Number

118802834

Active Ingredients

croscarmellose sodium

Code: M28OL1HH48

Class Code: IACT

Quantity: 50 mg in 1 1

Code: V63XWA605I

Class Code: ACTIM

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

povidone

Code: FZ989GH94E

Class Code: IACT

starch, corn

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

armodafinil

Code: V63XWA605I

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