©2011 Takeda Pharmaceuticals America, Inc.

February 2011
AZL069 R1

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Carton

Professional Sample-
Not for Sale

NDC 64764-844-07

Contains one
patient sample unit
of 7 tablets each.

edarbi
(azilsartan medoxomil)
tablets

40 mg per tablet

Each white tablet contains:
42.68 mg azilsartan kamedoxomil (equivalent to
40 mg azilsartan medoxomil).

Usual Dosage: See package insert.

Store at 25°C (77°F); excursions permitted to
15-30°C (59-86°F) [see USP Controlled Room
Temperature].

Protect from moisture and light.
Dispense and store in original container.

Rx Only

Takeda

Distributed by:
Takeda Pharmaceuticals
America, Inc.
Deerfield, IL 60015

C081-01

PRINCIPAL DISPLAY PANEL - 80 mg Tablet Carton

Professional Sample-
Not for Sale

NDC 64764-884-07
Contains one
patient sample unit
of 7 tablets each.

edarbi
(azilsartan medoxomil)
tablets
80 mg per tablet
Each white tablet contains:
85.36 mg azilsartan kamedoxomil (equivalent to
80 mg azilsartan medoxomil).
Usual Dosage: See package insert.

Store at 25°C (77°F); excursions permitted to
15-30°C (59-86°F) [see USP Controlled Room
Temperature].

Protect from moisture and light.
Dispense and store in original container.

Rx Only
Takeda
Distributed by:
Takeda Pharmaceuticals
America, Inc.
Deerfield, IL 60015
C082-01

EDARBI 
azilsartan medoxomil   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64764-844
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan medoxomil (Azilsartan)  Azilsartan medoxomil 40 mg
 
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
 
Product Characteristics
Color WHITE (White to nearly white)  Score no score 
Shape ROUND Size 8mm
Flavor  Imprint Code ASL;40 
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 64764-844-07 5 CARTON In 1 TRAY contains a CARTON
1  1 BLISTER PACK In 1 CARTON This package is contained within the TRAY (64764-844-07) and contains a BLISTER PACK
1  7 TABLET In 1 BLISTER PACK This package is contained within a CARTON and a TRAY (64764-844-07)
2 64764-844-30 30 TABLET In 1 BOTTLE None
3 64764-844-90 90 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200796 02/25/2011 

EDARBI 
azilsartan medoxomil   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64764-884
Route of Administration ORAL DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan medoxomil (Azilsartan)  Azilsartan medoxomil 80 mg
Inactive Ingredients
Ingredient Name Str