Olanzapine (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

OLANZAPINE tablets

30 tablets

123
(click image for full-size original)

Rx Only OLANZAPINE tablets

15 mg

30 tablets

234
(click image for full-size original)

Rx Only OLANZAPINE tablets

10 mg

30 tablets

555
(click image for full-size original)

Rx Only OLANZAPINE tablets

7.5 mg

30 tablets

678
(click image for full-size original)

Rx Only

OLANZAPINE tablets

30 tablets

888
(click image for full-size original)

Rx Only

OLANZAPINE tablets

30 tablets

987
(click image for full-size original)

Rx Only

OLANZAPINE tablets

20 mg

100 (10×10 unit dose blister)

543
(click image for full-size original)

Rx Only

OLANZAPINE tablets

15 mg

100 (10×10 unit dose blister)

444
(click image for full-size original)

Rx Only

OLANZAPINE tablets

10 mg

100 (10×10 unit dose blister)

658
(click image for full-size original)

Rx Only

OLANZAPINE tablets

7.5 mg

100 (10×10 unit dose blister)

688
(click image for full-size original)

Rx Only

OLANZAPINE tablets

5 mg

100 (10×10 unit dose blister)

777
(click image for full-size original)

Rx Only

OLANZAPINE tablets

2.5 mg

100 (10×10 unit dose blister)

800
(click image for full-size original)
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-067
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code CL39
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-067-07 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-067-44 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:33342-067-12 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (33342-067-12)
4 NDC:33342-067-11 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 08/22/2014
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-068
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, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code CL40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-068-07 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-068-44 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:33342-068-12 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (33342-068-12)
4 NDC:33342-068-11 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 08/22/2014
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-069
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code CL41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-069-07 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-069-44 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:33342-069-12 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (33342-069-12)
4 NDC:33342-069-11 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 08/22/2014
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-070
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Biconvex) Size 11mm
Flavor Imprint Code CL42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-070-07 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-070-15 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:33342-070-12 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (33342-070-12)
4 NDC:33342-070-44 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:33342-070-11 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 08/22/2014
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-071
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape OVAL (Biconvex) Size 13mm
Flavor Imprint Code CL43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-071-07 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-071-15 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:33342-071-12 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (33342-071-12)
4 NDC:33342-071-44 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:33342-071-11 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 08/22/2014
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-072
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape OVAL (Biconvex) Size 14mm
Flavor Imprint Code CL44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-072-07 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:33342-072-15 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:33342-072-12 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (33342-072-12)
4 NDC:33342-072-44 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:33342-072-11 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 08/22/2014
Labeler — Macleods Pharmaceuticals Limited (862128535)
Establishment
Name Address ID/FEI Operations
Macleods Pharmaceuticals Limited 676369519 ANALYSIS (33342-067), ANALYSIS (33342-068), ANALYSIS (33342-069), ANALYSIS (33342-070), ANALYSIS (33342-071), ANALYSIS (33342-072), LABEL (33342-067), LABEL (33342-068), LABEL (33342-069), LABEL (33342-070), LABEL (33342-071), LABEL (33342-072), MANUFACTURE (33342-067), MANUFACTURE (33342-068), MANUFACTURE (33342-069), MANUFACTURE (33342-070), MANUFACTURE (33342-071), MANUFACTURE (33342-072), PACK (33342-067), PACK (33342-068), PACK (33342-069), PACK (33342-070), PACK (33342-071), PACK (33342-072)

Revised: 09/2022 Macleods Pharmaceuticals Limited

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