Olanzapine (Page 13 of 13)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

5 mg Container Label

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5 mg Carton Label:

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7.5 mg Container Label:

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7.5 mg Carton Label:

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10 mg Container Label

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10 mg Carton Label

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OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
HYDROXYPROPYL CELLULOSE (110000 WAMW)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
hypromelloses
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 400
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code R5;0164
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-164-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-164-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-164-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-164-10 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:43598-164-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (43598-164-79)
5 NDC:43598-164-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (43598-164-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 12/10/2013
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-165
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 (110000 WAMW)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
hypromelloses
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 400
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9mm
Flavor Imprint Code R7;5;0165
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-165-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-165-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-165-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-165-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:43598-165-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (43598-165-79)
5 NDC:43598-165-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (43598-165-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 12/10/2013
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
HYDROXYPROPYL CELLULOSE (110000 WAMW)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
hypromelloses
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 400
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code R10;0166
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-166-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-166-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-166-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-166-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:43598-166-10 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:43598-166-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (43598-166-79)
6 NDC:43598-166-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (43598-166-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 12/10/2013
Labeler — Dr. Reddy’s Laboratories Inc. (802315887)
Establishment
Name Address ID/FEI Operations
Dr.Reddy’s Laboratories Limited-FTO3 918608162 analysis (43598-164), manufacture (43598-164), analysis (43598-165), manufacture (43598-165), analysis (43598-166), manufacture (43598-166)

Revised: 10/2022 Dr. Reddy’s Laboratories Inc.

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