OLANZAPINE (Page 12 of 12)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (30 Tablets Bottle)

NDC 66993-680-30
PRASCO
30 Tablets
Rx only
Olanzapine Tablets, USP 2.5 mg
PHARMACIST: Dispense the accompanyingMedication Guide to each patient

olanzapine2 5mg30ct.jpg
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olanzapine2 5mg30ct.jpg

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (30 Tablets Bottle)

NDC 66993-681-30
PRASCO
30 Tablets
Rx only
Olanzapine Tablets, USP 5 mg
PHARMACIST: Dispense the accompanyingMedication Guide to each patient

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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 7.5 mg (30 Tablets Bottle)

NDC 66993-682-30
PRASCO
30 Tablets
Rx only
Olanzapine Tablets, USP 7.5 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient

olanzapine7 5mg30ct.jpg
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Bottle)

NDC 66993-683-30
PRASCO
30 Tablets
Rx only
Olanzapine Tablets, USP 10 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient

//medlibrary.org/lib/images-rx/olanzapine-52/olanzapine10mg30ct-300x104.jpg
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 15 mg (30 Tablets Bottle)

NDC 66993-684-30
PRASCO
30 Tablets
Rx only
Olanzapine Tablets, USP 15 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient

//medlibrary.org/lib/images-rx/olanzapine-52/olanzapine15mg30ct-300x106.jpg
(click image for full-size original)

olanzapine15mg30ct.jpg

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (30 Tablets Bottle)

NDC 66993-685-30
PRASCO
30 Tablets
Rx only
Olanzapine Tablets, USP 20 mg
PHARMACIST: Dispense the accompanyingMedication Guide to each patient

//medlibrary.org/lib/images-rx/olanzapine-52/olanzapine20mg30ct-300x105.jpg
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OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-680
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
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 5mm
Flavor Imprint Code C;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-680-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/23/2012
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-681
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
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code C;46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-681-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/23/2012
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-682
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
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code C;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-682-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/23/2012
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-683
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
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code C;48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-683-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/23/2012
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-684
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
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code C;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-684-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/23/2012
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-685
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Biconvex) Size 11mm
Flavor Imprint Code C;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-685-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/23/2012
Labeler — Prasco Laboratories (065969375)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma, LLC 829084461 MANUFACTURE (66993-680), MANUFACTURE (66993-681), MANUFACTURE (66993-682), MANUFACTURE (66993-683), MANUFACTURE (66993-684), MANUFACTURE (66993-685)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917662 ANALYSIS (66993-680), ANALYSIS (66993-681), ANALYSIS (66993-682), ANALYSIS (66993-683), ANALYSIS (66993-684), ANALYSIS (66993-685), API MANUFACTURE (66993-680), API MANUFACTURE (66993-681), API MANUFACTURE (66993-682), API MANUFACTURE (66993-683), API MANUFACTURE (66993-684), API MANUFACTURE (66993-685)

Revised: 12/2020 Prasco Laboratories

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