Xtandi (Page 7 of 7)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Xtandi (enzalutamide) tablets 40 mg label
(click image for full-size original)

NDC 0469-0625-99

Rx Only

Xtandi®
(enzalutamide)
tablets

40 mg

Swallow tablets whole. Do not cut, crush, or chew the tablets.

120 Tablets

Manufactured by Pfizer Pharmaceuticals LLC, for Astellas Pharma US, Inc., Northbrook, IL 60062

PAA135442

234833-XTA-USA

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Xtandi (enzalutamide) tablets 80 mg label
(click image for full-size original)

NDC 0469-0725-60

Rx Only

Xtandi®
(enzalutamide)
tablets

80 mg

Swallow tablets whole. Do not cut, crush, or chew the tablets.

60 Tablets

Manufactured by Pfizer Pharmaceuticals LLC, for Astellas Pharma US, Inc., Northbrook, IL 60062

PAA135444

234833-XTA-USA

XTANDI enzalutamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-0625
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENZALUTAMIDE (ENZALUTAMIDE) ENZALUTAMIDE 40 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code E;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0469-0625-99 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 TABLET in 1 BOTTLE This package is contained within the CARTON (0469-0625-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213674 08/04/2020
XTANDI enzalutamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-0725
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENZALUTAMIDE (ENZALUTAMIDE) ENZALUTAMIDE 80 mg
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 17mm
Flavor Imprint Code E;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0469-0725-60 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET in 1 BOTTLE This package is contained within the CARTON (0469-0725-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213674 08/04/2020
Labeler — Astellas Pharma US, Inc. (605764828)

Revised: 08/2020 Astellas Pharma US, Inc.

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