Capecitabine (Page 14 of 14)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 0093-7473-08

Capecitabine Tablets USP

150 mg

Cytotoxic Agent

PHARMACIST: Please dispense with accompanying Patient Information leaflet.

Rx only

60 TABLETS

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 0093-7474-89

Capecitabine Tablets USP

500 mg

Cytotoxic Agent

PHARMACIST: Please dispense with accompanying Patient Information leaflet.

Rx only

120 TABLETS

CAPECITABINE capecitabine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7473 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 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color orange (peach to light peach) Score no score Shape OVAL (oblong) Size 11mm Flavor Imprint Code 190;77 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-7473-06 60 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091649 03/07/2014

CAPECITABINE capecitabine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7474 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 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color orange (peach to light peach) Score no score Shape OVAL (oblong) Size 16mm Flavor Imprint Code 191;77 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-7474-89 120 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091649 03/07/2014

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 09/2021 Teva Pharmaceuticals USA, Inc.