Xeloda (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Carton

NDC 0004-1100-20

Xeloda®
(capecitabine)
Tablets

150 mg

Each tablet contains 150 mgcapecitabine.

Warning: Hazardous Drug

Rx only

60 tablets

Genentech

10250281

PRINCIPAL DISPLAY PANEL -- 150 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Carton

NDC 0004-1101-50

Xeloda®
(capecitabine)
Tablets

500 mg

Each tablet contains 500 mgcapecitabine.

Warning: Hazardous Drug

Rx only

120 tablets

Genentech

10250280

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Carton
(click image for full-size original)
XELODA capecitabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0004-1100
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
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2208 (3 MPA.S)
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color PINK (light peach) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code XELODA;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0004-1100-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020896 04/30/1998
XELODA capecitabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0004-1101
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
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2208 (3 MPA.S)
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color PINK (peach) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code XELODA;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0004-1101-50 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020896 04/30/1998
Labeler — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Excella GmbH & Co. KG 329809800 ANALYSIS (0004-1100), ANALYSIS (0004-1101), MANUFACTURE (0004-1100), MANUFACTURE (0004-1101), PACK (0004-1100), PACK (0004-1101), LABEL (0004-1100), LABEL (0004-1101)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 485244961 ANALYSIS (0004-1100), ANALYSIS (0004-1101)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche AG 482242971 ANALYSIS (0004-1100), ANALYSIS (0004-1101)
Establishment
Name Address ID/FEI Operations
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. 431189117 ANALYSIS (0004-1100), ANALYSIS (0004-1101), API MANUFACTURE (0004-1100), API MANUFACTURE (0004-1101)

Revised: 11/2023 Genentech, Inc.

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