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 40mg
Inactive Ingredients
Ingredient Name Strength
mannitol
fumaric acid
sodium hydroxide
hydroxypropyl cellulose
croscarmellose sodium
cellulose, microcrystalline
magnesium stearate
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 5CARTONIn1TRAY contains a CARTON
1 1BLISTER PACKIn1CARTON This package is contained within the TRAY(64764-844-07) andcontains a BLISTER PACK
1 7TABLETIn1BLISTER PACK This package is contained within a CARTON and a TRAY(64764-844-07)
2 64764-844-30 30TABLETIn1BOTTLE None
3 64764-844-90 90TABLETIn1BOTTLE 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 80mg
Inactive Ingredients
Ingredient Name Strength
mannitol
fumaric acid
sodium hydroxide
hydroxypropyl cellulose
croscarmellose sodium
cellulose, microcrystal
