ONE (UNII: 92RU3N3Y1O)
Gelatin (UNII: 2G86QN327L)
sodium lauryl sulfate (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
Color BLUE (opaque blue) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code LILLY;3229;40;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 08/31/2014
STRATTERA
atomoxetine hydrochloride kit
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-5801
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0002-5801-62 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/31/2014
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 5
Part 2 5
Part 3 5
Part 4 30
Part 1 of 4
STRATTERA
atomoxetine hydrochloride capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8) Atomoxetine 18 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
STARCH, Corn (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
Gelatin (UNII: 2G86QN327L)
sodium lauryl sulfate (UNII: 368GB5141J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
Color WHITE (opaque white) , yellow (gold) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code LILLY;3238;18;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411
Part 2 of 4
STRATTERA
atomoxetine hydrochloride capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8) Atomoxetine 25 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
STARCH, Corn (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
Gelatin (UNII: 2G86QN327L)
sodium lauryl sulfate (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
Color WHITE (opaque white) , BLUE (opaque blue) Score no score
S |
