Olanzapine: Package Insert and Label Information (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

2.5 mg Container label

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

5 mg Container label

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

10 mg Container label

10 mg Container label
(click image for full-size original)
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69807-2013
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 (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69807-2013-1 1 BOTTLE in 1 BOTTLE contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the BOTTLE (69807-2013-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209399 09/24/2018
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69807-2012
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 (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69807-2012-1 1 BOTTLE in 1 BOTTLE contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the BOTTLE (69807-2012-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209399 09/24/2018
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69807-2011
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 (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69807-2011-1 1 BOTTLE in 1 BOTTLE contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the BOTTLE (69807-2011-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209399 09/24/2018
Labeler — Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (547876677)

Revised: 01/2020 Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.