NDC Code(s) : 55154-8298-0, 55154-8299-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OlanzapineOlanzapine TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8298(NDC:0093-5245)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE(UNII: N7U69T4SZR)
(OLANZAPINE - UNII:N7U69T4SZR) 		OLANZAPINE5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
STRAWBERRY(UNII: 4J2TY8Y81V)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7 mm
Flavor STRAWBERRY Imprint Code TV;U1;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-8298-01 in 1 BAG
110 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077243 02/17/2012
OlanzapineOlanzapine TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8299(NDC:0093-5246)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE(UNII: N7U69T4SZR)
(OLANZAPINE - UNII:N7U69T4SZR) 		OLANZAPINE10 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
STRAWBERRY(UNII: 4J2TY8Y81V)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 9 mm
Flavor STRAWBERRY Imprint Code TV;U2;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-8299-01 in 1 BAG
110 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077243 02/17/2012

PRINCIPAL DISPLAY PANEL

Olanzapine Orally Disintegrating Tablets

5 mg

10 Tablets

Bag Label

PRINCIPAL DISPLAY PANEL

Olanzapine Orally Disintegrating Tablets

10 mg

10 Tablets

Bag