Zyprexa (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

ZYPREXA

Olanzapine Tablets

2.5 mg

Rx only

Medication Guide is to be dispensed to patients.

zyprexa.com

image of 2.5 mg package label
(click image for full-size original)

ZYPREXA

Olanzapine Tablets

5 mg

Rx only

Medication Guide is to be dispensed to patients.

zyprexa.com

image of 5 mg package label
(click image for full-size original)

ZYPREXA

Olanzapine Tablets

7.5 mg

Rx only

Medication Guide is to be dispensed to patients.

zyprexa.com

image of 7.5 mg package label
(click image for full-size original)

ZYPREXA

Olanzapine Tablets

10 mg

Rx only

Medication Guide is to be dispensed to patients.

zyprexa.com

image of 10 mg package label
(click image for full-size original)
ZYPREXA olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4255(NDC:0002-4112)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code LILLY;4112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4255-0 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-4255-1 15 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020592 08/20/2003
ZYPREXA olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4254(NDC:0002-4115)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code LILLY;4115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4254-0 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-4254-1 60 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020592 09/30/2003
ZYPREXA olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5336(NDC:0002-4116)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code LILLY;4116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5336-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020592 06/14/2005
ZYPREXA olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3941(NDC:0002-4117)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code LILLY;4117
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3941-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020592 06/20/2003
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 11/2009 Physicians Total Care, Inc.

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