Armodafinil (Page 7 of 7)

Package/Label Display Panel

NDC 0093-3090 -56
Armodafinil Tablets 50 mg CIV
Medication Guide Required: Each time Armodafinil tablets are dispensed, give the patient a Medication Guide.
Rx only
30 TABLETS TEVA

50mg label
(click image for full-size original)

Package/Label Display Panel

NDC 0093-3092 -56
Armodafinil Tablets 150 mg CIV
Medication Guide Required: Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
Rx only
30 TABLETS TEVA

150mg label
(click image for full-size original)

Package/Label Display Panel

NDC 0093-3093 -56
Armodafinil Tablets 200 mg CIV
Medication Guide Required: Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
Rx only
30 TABLETS TEVA

200mg label
(click image for full-size original)

Package/Label Display Panel

NDC 0093-3094 -56
Armodafinil Tablets 250 mg CIV
Medication Guide Required: Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
Rx only
30 TABLETS TEVA

250mg label
(click image for full-size original)
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3090
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARMODAFINIL (ARMODAFINIL) ARMODAFINIL 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code C;205
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3090-56 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021875 11/29/2016
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3092
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARMODAFINIL (ARMODAFINIL) ARMODAFINIL 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code C;215
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3092-56 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021875 11/29/2016
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3093
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARMODAFINIL (ARMODAFINIL) ARMODAFINIL 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
Product Characteristics
Color white (white to off-white) Score no score
Shape RECTANGLE (rounded, rectanglar) Size 12mm
Flavor Imprint Code C;220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3093-56 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021875 11/29/2016
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3094
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARMODAFINIL (ARMODAFINIL) ARMODAFINIL 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code C;225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3094-56 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021875 11/29/2016
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)
Establishment
Name Address ID/FEI Operations
Pliva Hrvatska d.o.o. 500651871 api manufacture (0093-3090), api manufacture (0093-3092), api manufacture (0093-3093), api manufacture (0093-3094)

Revised: 12/2018 Teva Pharmaceuticals USA, Inc.

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