Olanzapine: Package Insert and Label Information (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

Olanzapine Tablets USP 5mg 30s Label Text

NDC 54868-6365-0

OLANZAPINE
Tablets USP
5 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only

30 TABLETS

PRINCIPAL DISPLAY PANEL

Olanzapine Tablets USP 7.5mg 30s Label Text

NDC 54868-6364-0

OLANZAPINE
Tablets USP
7.5 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only

30 TABLETS

PRINCIPAL DISPLAY PANEL

Olanzapine Tablets USP 15mg 30s Label Text

NDC 54868-6358-0

OLANZAPINE
Tablets USP
15 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only

30 TABLETS

OLANZAPINE olanzapine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6358(NDC:0093-5771) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE (OLANZAPINE) OLANZAPINE 15 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CARRAGEENAN CROSPOVIDONE FD&C BLUE NO. 2 ALUMINUM OXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS

Product Characteristics Color BLUE Score no score Shape OVAL (CAPSULE) Size 12mm Flavor Imprint Code TEVA;5771 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-6358-0 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076000 07/02/2012

OLANZAPINE olanzapine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6365(NDC:0093-5768) 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 ANHYDROUS LACTOSE CARRAGEENAN CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE

Product Characteristics Color WHITE (Off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code TEVA;5768 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-6365-0 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076000 08/22/2012

OLANZAPINE olanzapine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6364(NDC:0093-5769) 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 ANHYDROUS LACTOSE CARRAGEENAN CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE

Product Characteristics Color WHITE (Off-white) Score no score Shape ROUND Size 9mm Flavor Imprint Code TEVA;5769 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-6364-0 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076000 08/22/2012

Labeler — Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel (54868-6358), relabel (54868-6364), relabel (54868-6365)

Revised: 08/2012 Physicians Total Care, Inc.