Edarbyclor (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg Tablet Bottle Label

NDC 60631-412-30
30 Tablets

edarbyclor

Azilsartan Medoxomil and
Chlorthalidone Tablets

40 mg*/12.5 mg

Rx Only

*Each tablet contains:
42.68 mg azilsartan kamedoxomil
(equivalent to 40 mg
azilsartan medoxomil) and
12.5 mg chlorthalidone.

Dispense
and store
in originalcontainer.

PRINCIPAL DISPLAY PANEL -- 40 mg/12.5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg/25 mg Tablet Bottle Label

NDC 60631-425-30
30 Tablets

edarbyclor

Azilsartan Medoxomil and
Chlorthalidone Tablets

40 mg* /25 mg

Rx Only

*Each tablet contains:
42.68 mg azilsartan kamedoxomil
(equivalent to 40 mg
azilsartan medoxomil) and
25 mg chlorthalidone.

Dispense
and store
in originalcontainer.

PRINCIPAL DISPLAY PANEL -- 40 mg/25 mg Tablet Bottle Label
(click image for full-size original)
EDARBYCLOR azilsartan kamedoxomil and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60631-412
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan kamedoxomil (AZILSARTAN) AZILSARTAN MEDOXOMIL 40 mg
chlorthalidone (chlorthalidone) chlorthalidone 12.5 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
polyethylene glycol 8000
BUTYL ALCOHOL
CROSPOVIDONE (120 .MU.M)
water
FUMARIC ACID
SODIUM HYDROXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
SHELLAC
FERROSOFERRIC OXIDE
ALCOHOL
Product Characteristics
Color RED (pale red) Score no score
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code AC;40;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60631-412-07 5 BLISTER PACK in 1 TRAY contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the TRAY (60631-412-07)
2 NDC:60631-412-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202331 02/01/2013
EDARBYCLOR azilsartan kamedoxomil and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60631-425
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azilsartan kamedoxomil (AZILSARTAN) AZILSARTAN MEDOXOMIL 40 mg
chlorthalidone (chlorthalidone) chlorthalidone 25 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
MICROCRYSTALLINE CELLULOSE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
polyethylene glycol 8000
BUTYL ALCOHOL
CROSPOVIDONE (120 .MU.M)
water
FUMARIC ACID
SODIUM HYDROXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
SHELLAC
FERROSOFERRIC OXIDE
ALCOHOL
Product Characteristics
Color RED (light red) Score no score
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code AC;40;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60631-425-07 5 BLISTER PACK in 1 TRAY contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the TRAY (60631-425-07)
2 NDC:60631-425-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202331 02/01/2013
Labeler — Arbor Pharmaceuticals (781796417)

Revised: 06/2020 Arbor Pharmaceuticals

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