Edarbi (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

NDC 60631-040-30

edarbi
(azilsartan medoxomil)
tablets

40 mg

Manufactured for:
arborâ„¢
PHARMACEUTICALS, LLC.
Atlanta, GA 30328

Manufactured by:
TakedaOsaka, Japan

PRINCIPAL DISPLAY PANEL -- 40 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 60631-080-30

edarbi
(azilsartan medoxomil)
tablets

80 mg

Manufactured for:
arborâ„¢
PHARMACEUTICALS, LLC.
Atlanta, GA 30328

Manufactured by:
TakedaOsaka, Japan

PRINCIPAL DISPLAY PANEL -- 80 mg Tablet Bottle Label
(click image for full-size original)
EDARBI azilsartan kamedoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60631-040
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan kamedoxomil (Azilsartan) Azilsartan medoxomil 40 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
fumaric acid
sodium hydroxide
hydroxypropyl cellulose (type h)
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
# Item Code Package Description Multilevel Packaging
1 NDC:60631-040-07 5 BLISTER PACK in 1 TRAY contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the TRAY (60631-040-07)
2 NDC:60631-040-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200796 02/01/2013
EDARBI azilsartan kamedoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60631-080
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan kamedoxomil (Azilsartan) Azilsartan medoxomil 80 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
fumaric acid
sodium hydroxide
hydroxypropyl cellulose (type h)
croscarmellose sodium
cellulose, microcrystalline
magnesium stearate
Product Characteristics
Color WHITE (White to nearly white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code ASL;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60631-080-07 5 BLISTER PACK in 1 TRAY contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the TRAY (60631-080-07)
2 NDC:60631-080-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200796 02/01/2013
Labeler — Arbor Pharmaceuticals Ireland Limited (985060592)

Revised: 08/2015 Arbor Pharmaceuticals Ireland Limited

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