Olanzapine (Page 12 of 12)

Package/Label Display Panel – Carton – 2.5 mg

2.5 mg Olanzapine Tablets Carton
(click image for full-size original)

NDC 68084- 525 -01

Olanzapine
Tablets, USP

2.5 mg

100 Tablets (10 x10)               Rx Only

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Film-Coated Tablet Contains:
Olanzapine USP …………………………………………2.5 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see USP
Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC #55111-163 Dr. Reddy’s Laboratories Limited.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

052501 0252501/1018OS

Package/Label Display Panel – Blister – 2.5 mg

2.5 mg Olanzapine Tablet Blister
(click image for full-size original)

Olanzapine Tablet, USP

2.5 mg

Package/Label Display Panel – Carton – 5 mg

5 mg Olanzapine Tablets Carton
(click image for full-size original)

NDC 68084- 723 -01

Olanzapine
Tablets, USP

5 mg

100 Tablets (10 x10)               Rx Only

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Film-Coated Tablet Contains:
Olanzapine USP……………………………………………5 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see USP
Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 43598-164 Dr. Reddy’s Laboratories Limited.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

072301 0272301/1018OS

Package/Label Display Panel – Blister – 5 mg

5 mg Olanzapine Tablet Blister
(click image for full-size original)

Olanzapine Tablet, USP

5 mg

Package/Label Display Panel – Carton – 10 mg

10 mg Olanzapine Tablets Carton
(click image for full-size original)

NDC 68084- 740 -01

Olanzapine
Tablets, USP

10 mg

100 Tablets (10 x10)               Rx Only

PHARMACIST: Dispense with the accompanying
Medication Guide to each patient.

Each Film-Coated Tablet Contains:
Olanzapine USP………………………………………….10 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see USP
Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 43598-166 Dr. Reddy’s Laboratories Limited.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

074001 0274001/1018OS

Package/Label Display Panel – Blister – 10 mg

10 mg Olanzapine Tablet Blister
(click image for full-size original)

Olanzapine Tablet, USP

10 mg

OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-525(NDC:55111-163)
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 (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 8mm
Flavor Imprint Code R;2;5;0163
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-525-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-525-11)
1 NDC:68084-525-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-525-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 04/25/2012
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-723(NDC:43598-164)
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 (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 8mm
Flavor Imprint Code R;5;0164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-723-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-723-11)
1 NDC:68084-723-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-723-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 04/07/2014
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-740(NDC:43598-166)
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 (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 10mm
Flavor Imprint Code R;10;0166
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-740-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-740-11)
1 NDC:68084-740-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-740-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 04/07/2014
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-525), repack (68084-723), repack (68084-740)

Revised: 10/2022 American Health Packaging

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