Olanzapine (Page 15 of 15)

PRINCIPAL DISPLAY PANEL — 2.5 mg

NDC 42292-012-20

Olanzapine Tablets, USP
2.5 mg

100 Tablets (10 x 10)

Each tablet contains:
Olanzapine USP 2.5 mg.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302, India M.L.No.: 22/MN/AP/2009/F/R

Rx only

S-12280

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

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

Olanzapine 2.5 mg Tablets Unit Carton LabelUnit Carton

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 42292-013-20

Olanzapine Tablets, USP
5 mg

100 Tablets (10 x 10)

Each tablet contains:
Olanzapine USP 5 mg.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302, India M.L.No.: 22/MN/AP/2009/F/R

Rx only

S-12281

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

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

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 42292-014-20

Olanzapine Tablets, USP
10 mg

100 Tablets (10 x 10)

Each tablet contains:
Olanzapine USP 10 mg.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302, India M.L.No.: 22/MN/AP/2009/F/R

Rx only

S-12282

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

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

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 42292-015-20

Olanzapine Tablets, USP
15 mg

100 Tablets (10 x 10)

Each tablet contains:
Olanzapine USP 15 mg.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302, India M.L.No.: 22/MN/AP/2009/F/R

Rx only

S-12283

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Olanzapine 15 mg Tablets Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 42292-016-20

Olanzapine Tablets, USP
20 mg

100 Tablets (10 x 10)

Each tablet contains:
Olanzapine USP 20 mg.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302, India M.L.No.: 22/MN/AP/2009/F/R

Rx only

S-12284

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Olanzapine 20 mg Tablets Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-012(NDC:65862-561)
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 (TYPE H)
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:42292-012-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-012-01)
1 NDC:42292-012-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-012-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 05/10/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-013(NDC:65862-562)
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 (TYPE H)
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:42292-013-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-013-01)
1 NDC:42292-013-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-013-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/26/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-014(NDC:65862-564)
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 (TYPE H)
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:42292-014-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-014-01)
1 NDC:42292-014-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-014-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-015(NDC:65862-565)
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 (TYPE H)
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:42292-015-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-015-01)
1 NDC:42292-015-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-015-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-016(NDC:65862-566)
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 (TYPE H)
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:42292-016-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (42292-016-01)
1 NDC:42292-016-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (42292-016-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202050 04/28/2016
Labeler — Mylan Institutional Inc. (039615992)

Revised: 06/2016 Mylan Institutional Inc.

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