Olanzapine (Page 14 of 14)

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

NDC 67184 -0561- 1 30 Tablets

Olanzapine Tablets, USP

2.5 mg

PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.

KEEP THIS AND ALL DRUGS OUT OF THE REACH
OF CHILDREN.

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2.5 mg (30 Tablets Bottle)
(click image for full-size original)

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

NDC 67184 -0562- 1 30 Tablets

Olanzapine Tablets, USP

5 mg

PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (30 Tablets Bottle)
(click image for full-size original)

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

NDC 67184 -0563- 1 30 Tablets

Olanzapine Tablets, USP

7.5 mg

PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN..

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 7.5 mg (30 Tablets Bottle)
(click image for full-size original)

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

NDC 67184 -0564- 1 30 Tablets

Olanzapine Tablets, USP

10 mg

PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 15 mg (30 Tablets Bottle)

NDC 67184- 0565 -1 30 Tablets

Olanzapine Tablets, USP

15 mg

PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 15 mg (30 Tablets Bottle)
(click image for full-size original)

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

NDC 67184- 0566 -1 30 Tablets

Olanzapine Tablets, USP

20 mg

PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (30 Tablets Bottle)
(click image for full-size original)
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67184-0561
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, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code 11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67184-0561-1 30 TABLET in 1 BOTTLE None
2 NDC:67184-0561-2 100 TABLET in 1 BOTTLE None
3 NDC:67184-0561-6 90 TABLET in 1 BOTTLE None
4 NDC:67184-0561-3 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204319 01/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67184-0562
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
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSE 2910 (6 MPA.S)
SODIUM LAURYL SULFATE
CROSPOVIDONE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code 12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67184-0562-1 30 TABLET in 1 BOTTLE None
2 NDC:67184-0562-2 100 TABLET in 1 BOTTLE None
3 NDC:67184-0562-6 90 TABLET in 1 BOTTLE None
4 NDC:67184-0562-3 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204319 01/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67184-0563
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, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code 13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67184-0563-1 30 TABLET in 1 BOTTLE None
2 NDC:67184-0563-2 100 TABLET in 1 BOTTLE None
3 NDC:67184-0563-6 90 TABLET in 1 BOTTLE None
4 NDC:67184-0563-4 800 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204319 01/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67184-0564
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, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code 14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67184-0564-1 30 TABLET in 1 BOTTLE None
2 NDC:67184-0564-2 100 TABLET in 1 BOTTLE None
3 NDC:67184-0564-6 90 TABLET in 1 BOTTLE None
4 NDC:67184-0564-5 600 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204319 01/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67184-0565
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, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
Product Characteristics
Color blue Score no score
Shape OVAL (Biconvex) Size 13mm
Flavor Imprint Code 15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67184-0565-1 30 TABLET in 1 BOTTLE None
2 NDC:67184-0565-2 100 TABLET in 1 BOTTLE None
3 NDC:67184-0565-6 90 TABLET in 1 BOTTLE None
4 NDC:67184-0565-4 800 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204319 01/27/2016
OLANZAPINE olanzapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67184-0566
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, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape OVAL (Biconvex) Size 15mm
Flavor Imprint Code 17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67184-0566-1 30 TABLET in 1 BOTTLE None
2 NDC:67184-0566-2 100 TABLET in 1 BOTTLE None
3 NDC:67184-0566-6 90 TABLET in 1 BOTTLE None
4 NDC:67184-0566-5 600 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204319 01/27/2016
Labeler — Qilu Pharmaceutical Co., Ltd. (653878256)
Establishment
Name Address ID/FEI Operations
Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) 421279342 manufacture (67184-0561), manufacture (67184-0562), manufacture (67184-0563), manufacture (67184-0564), manufacture (67184-0565), manufacture (67184-0566), analysis (67184-0561), analysis (67184-0562), analysis (67184-0563), analysis (67184-0564), analysis (67184-0565), analysis (67184-0566), pack (67184-0561), pack (67184-0562), pack (67184-0563), pack (67184-0564), pack (67184-0565), pack (67184-0566)
Establishment
Name Address ID/FEI Operations
Qilu Pharmaceutical Co., Ltd. 653878256 api manufacture (67184-0561), api manufacture (67184-0562), api manufacture (67184-0563), api manufacture (67184-0564), api manufacture (67184-0565), api manufacture (67184-0566), api manufacture (67184-0561), analysis (67184-0562), analysis (67184-0563), analysis (67184-0564), analysis (67184-0565), analysis (67184-0566), pack (67184-0561), pack (67184-0562), pack (67184-0563), pack (67184-0564), pack (67184-0565), pack (67184-0566)

Revised: 05/2018 Qilu Pharmaceutical Co., Ltd.

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