Xalkori (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 250 mg Capsule Bottle Label

ALWAYS DISPENSE ENCLOSED MEDICATION
GUIDE TO EACH PATIENT

Pfizer
NDC 0069-8140-20

XALKORI®
(crizotinib) capsules
250 mg

Swallow capsule whole

60 Capsules Rx only

PRINCIPAL DISPLAY PANEL -- 250 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Capsule Bottle Label

ALWAYS DISPENSE ENCLOSED MEDICATION
GUIDE TO EACH PATIENT

Pfizer
NDC 0069-8141-20

XALKORI®
(crizotinib) capsules
200 mg

Swallow capsule whole

60 Capsules Rx only

PRINCIPAL DISPLAY PANEL -- 200 mg Capsule Bottle Label
(click image for full-size original)
XALKORI crizotinib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-8140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CRIZOTINIB (CRIZOTINIB) CRIZOTINIB 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK (opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code Pfizer;CRZ;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-8140-20 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202570 08/26/2011
XALKORI crizotinib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-8141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CRIZOTINIB (CRIZOTINIB) CRIZOTINIB 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK (opaque) , WHITE (opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code Pfizer;CRZ;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-8141-20 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202570 08/26/2011
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 PACK (0069-8140), PACK (0069-8141), ANALYSIS (0069-8140), ANALYSIS (0069-8141)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985052076 ANALYSIS (0069-8140), ANALYSIS (0069-8141), API MANUFACTURE (0069-8140), API MANUFACTURE (0069-8141)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Deutschland GmbH 341970073 ANALYSIS (0069-8140), ANALYSIS (0069-8141), MANUFACTURE (0069-8140), MANUFACTURE (0069-8141), PACK (0069-8140), PACK (0069-8141)
Establishment
Name Address ID/FEI Operations
Upjohn Manufacturing Ireland Unlimited Company 986030667 ANALYSIS (0069-8140), ANALYSIS (0069-8141), API MANUFACTURE (0069-8140), API MANUFACTURE (0069-8141)
Establishment
Name Address ID/FEI Operations
Pfizer Asia Manufacturing Pte Ltd 936889401 ANALYSIS (0069-8140), ANALYSIS (0069-8141), API MANUFACTURE (0069-8140), API MANUFACTURE (0069-8141)

Revised: 10/2022 Pfizer Laboratories Div Pfizer Inc

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