NDC Code(s) : 55154-0975-6, 55154-0975-4, 55154-0975-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PROVIGILmodafinil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-0975(NDC:63459-101)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
modafinil(UNII: R3UK8X3U3D)
(modafinil - UNII:R3UK8X3U3D) 		modafinil100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
lactose(UNII: J2B2A4N98G)
magnesium stearate(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
povidone(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color white Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code PROVIGIL;100;MG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-0975-4100 in 1 CARTON
1NDC:55154-0975-61 in 1 POUCH
2NDC:55154-0975-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020717 12/24/1998

PRINCIPAL DISPLAY PANEL

NDC: 55154-0975-4

CIV

Provigil®

(modafinil) Tablets

100 mg

100 Tablets

Each tablet contains: modafinil 100 mg

See product insert for full prescribing information, precautions and warnings.

STORAGE: Store at 20°-25°C (68°-77°F).

Dispense in a tight container as defined in the USP.

RX ONLY

WARNING: This package is intended for institutional use only. This package is not child resistant. Keep this and all drugs out of the reach of children.

See window for lot number and expiration date.

Manufactured for: Cephalon, Inc.

Frazer, PA 19355

US Patent Nos. RE 37,516/ 7,297,346

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUCC0284860610

Provigil Carton Label

PRINCIPAL DISPLAY PANEL

Provigil®

(modafinil) Tablet

CIV

100 mg

Provigil Pouch

PRINCIPAL DISPLAY PANEL

Provigil® 100 mg

Modafinil

10 Tablets

Bag Label