Modafinil (Page 7 of 7)

Principal Display Panel

NDC 0591-3499-30
Modafinil
Tablets, USP
CIV
100 mg
PHARMACIST: Dispense the
Medication Guide provided
separately to each patient.

Actavis
Rx only
30 Tablets

100mg
(click image for full-size original)

Principal Display Panel

NDC 0591-3500-30
Modafinil
Tablets, USP
CIV
200 mg
PHARMACIST: Dispense the
Medication Guide provided
separately to each patient.

Actavis
Rx only
30 Tablets

200mg
(click image for full-size original)
MODAFINIL modafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3499
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MODAFINIL (MODAFINIL) MODAFINIL 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CROSPOVIDONE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
Product Characteristics
Color WHITE (white) Score no score
Shape CAPSULE (capsule) Size 13mm
Flavor Imprint Code WPI;3154
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3499-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0591-3499-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076715 04/03/2013
MODAFINIL modafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3500
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MODAFINIL (MODAFINIL) MODAFINIL 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CROSPOVIDONE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape CAPSULE (capsule) Size 16mm
Flavor Imprint Code WPI;3155
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3500-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0591-3500-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076715 04/03/2013
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 12/2016 Actavis Pharma, Inc.

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