Armodafinil (Page 7 of 7)

Package/Label Display Panel

NDC 0781-8029 -31
Armodafinil Tablets CIV
50 mg
Rx only
Medication Guide Required:Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
30 Tablets
SANDOZ S

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

Package/Label Display Panel

NDC 0781-8037 -31
Armodafinil Tablets CIV
150 mg
Rx only
Medication Guide Required: Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
30 Tablets
SANDOZ S

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

Package/Label Display Panel

NDC 0781-8045 -31
Armodafinil Tablets CIV
200 mg
Rx only
Medication Guide Required:
Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
30 Tablets
SANDOZ S

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

Package/Label Display Panel

NDC 0781-8053 -31
Armodafinil Tablets CIV
250 mg
Rx only
Medication Guide Required: Each time armodafinil tablets are dispensed, give the patient a Medication Guide.
30 Tablets
SANDOZS

250mg label
(click image for full-size original)
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-8029
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:0781-8029-31 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 12/01/2016
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-8037
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:0781-8037-31 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 12/01/2016
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-8045
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:0781-8045-31 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 12/01/2016
ARMODAFINIL armodafinil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-8053
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:0781-8053-31 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 12/01/2016
Labeler — Sandoz Inc (005387188)
Establishment
Name Address ID/FEI Operations
Pliva Hrvatska d.o.o. 500651871 api manufacture (0781-8029), api manufacture (0781-8037), api manufacture (0781-8045), api manufacture (0781-8053)

Revised: 12/2018 Sandoz Inc

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