OLANZAPINE (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Olanzapine Tablets, USP, 2.5 mg

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

Olanzapine Tablets, USP, 5 mg

5 mg, tablet
(click image for full-size original)

Olanzapine Tablets, USP, 7.5 mg

7.5 mg, tablet
(click image for full-size original)

Olanzapine Tablets, USP, 10 mg

10  mg, tablet
(click image for full-size original)

Olanzapine Tablets, USP, 15 mg

15 mg, tablet
(click image for full-size original)

Olanzapine Tablets, USP, 20 mg

20 mg, tablet
(click image for full-size original)

Olanzapine Orally Disintegrating Tablets USP, 5 mg

5 mg Orally Disintegrating Tablets
(click image for full-size original)

Olanzapine Orally Disintegrating Tablets USP, 10 mg

10 mg, Orally Disintegrating Tablets
(click image for full-size original)

Olanzapine Orally Disintegrating Tablets USP, 15 mg

15 mg, Orally Disintegrating Tablets
(click image for full-size original)

Olanzapine Orally Disintegrating Tablets USP, 20 mg

20 mg,Orally Disintegrating Tablets
(click image for full-size original)
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-166
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 5mm
Flavor Imprint Code 2;5;66
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-166-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-166-74 100 TABLET in 1 CARTON None
3 NDC:13668-166-10 1000 TABLET in 1 BOTTLE None
4 NDC:13668-166-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-166-01 100 TABLET in 1 BOTTLE None
6 NDC:13668-166-60 60 TABLET in 1 BOTTLE None
7 NDC:13668-166-43 3000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091434 04/23/2012 06/30/2017
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-167
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code 5;67
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-167-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-167-74 100 TABLET in 1 CARTON None
3 NDC:13668-167-20 2000 TABLET in 1 BOTTLE None
4 NDC:13668-167-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-167-10 1000 TABLET in 1 BOTTLE None
6 NDC:13668-167-60 60 TABLET in 1 BOTTLE None
7 NDC:13668-167-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091434 04/23/2012 02/28/2021
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-168
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape CAPSULE (capsule) Size 7mm
Flavor Imprint Code 7;5;168
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-168-74 100 TABLET in 1 CARTON None
2 NDC:13668-168-20 2000 TABLET in 1 BOTTLE None
3 NDC:13668-168-10 1000 TABLET in 1 BOTTLE None
4 NDC:13668-168-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-168-01 100 TABLET in 1 BOTTLE None
6 NDC:13668-168-60 60 TABLET in 1 BOTTLE None
7 NDC:13668-168-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091434 04/23/2012 04/30/2017
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-169
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 8mm
Flavor Imprint Code 10;169
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-169-74 100 TABLET in 1 CARTON None
2 NDC:13668-169-15 1500 TABLET in 1 BOTTLE None
3 NDC:13668-169-10 1000 TABLET in 1 BOTTLE None
4 NDC:13668-169-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-169-01 100 TABLET in 1 BOTTLE None
6 NDC:13668-169-60 60 TABLET in 1 BOTTLE None
7 NDC:13668-169-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091434 04/23/2012 02/28/2021
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-170
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape OVAL (Oval) Size 10mm
Flavor Imprint Code 15;1170
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-170-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-170-74 100 TABLET in 1 CARTON None
3 NDC:13668-170-10 1000 TABLET in 1 BOTTLE None
4 NDC:13668-170-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-170-01 100 TABLET in 1 BOTTLE None
6 NDC:13668-170-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091434 04/23/2012 02/28/2021
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-171
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 10mm
Flavor Imprint Code 20;1171
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-171-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-171-74 100 TABLET in 1 CARTON None
3 NDC:13668-171-10 1000 TABLET in 1 BOTTLE None
4 NDC:13668-171-05 500 TABLET in 1 BOTTLE None
5 NDC:13668-171-01 100 TABLET in 1 BOTTLE None
6 NDC:13668-171-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091434 04/23/2012 02/28/2021
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-086
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
ASPARTAME
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code 86;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-086-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:13668-086-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:13668-086-74 100 TABLET, ORALLY DISINTEGRATING in 1 CARTON None
4 NDC:13668-086-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091415 10/25/2011
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-088
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
ASPARTAME
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 8mm
Flavor Imprint Code 88;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-088-74 100 TABLET, ORALLY DISINTEGRATING in 1 CARTON None
2 NDC:13668-088-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:13668-088-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
4 NDC:13668-088-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091415 10/25/2011
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-089
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
ASPARTAME
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 10mm
Flavor Imprint Code 89;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-089-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:13668-089-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:13668-089-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
4 NDC:13668-089-74 100 TABLET, ORALLY DISINTEGRATING in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091415 10/25/2011
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-090
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
ASPARTAME
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color yellow (Yellow) Score no score
Shape ROUND (Round) Size 11mm
Flavor Imprint Code 90;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-090-74 100 TABLET, ORALLY DISINTEGRATING in 1 CARTON None
2 NDC:13668-090-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:13668-090-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
4 NDC:13668-090-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091415 10/25/2011
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-166), manufacture (13668-167), manufacture (13668-168), manufacture (13668-169), manufacture (13668-170), manufacture (13668-171), manufacture (13668-086), manufacture (13668-088), manufacture (13668-089), manufacture (13668-090)

Revised: 06/2020 Torrent Pharmaceuticals Limited

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