Capecitabine 150mg (Page 13 of 13)

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

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CAPECITABINE 150MG capecitabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72606-554
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPECITABINE (CAPECITABINE) CAPECITABINE 150 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
WATER
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TALC
Product Characteristics
Color pink (Light pink) Score no score
Shape capsule (Capsule shaped biconvex) Size 11mm
Flavor Imprint Code CAP;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72606-554-01 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207456 11/06/2019
CAPECITABINE 500MG capecitabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72606-555
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPECITABINE (CAPECITABINE) CAPECITABINE 500 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
WATER
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TALC
Product Characteristics
Color pink (Dark Pink) Score no score
Shape capsule (Capsule shaped biconvex) Size 16mm
Flavor Imprint Code CAP;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72606-555-01 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207456 11/06/2019
Labeler — CELLTRION USA, INC. (116587378)
Establishment
Name Address ID/FEI Operations
Shilpa Medicare Ltd. 650644136 manufacture (72606-554), manufacture (72606-555)

Revised: 11/2019 CELLTRION USA, INC.

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