ATACAND (Page 7 of 7)

PRINCIPAL DISPLAY PANEL – 4 mg

NDC 62559-640-30
ATACAND® (candesartan cilexetil) Tablets
4 mg
Rx only
30 Tablets

Label-4mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 8 mg

NDC 62559-641-30
ATACAND® (candesartan cilexetil) Tablets
8 mg
Rx only
30 Tablets

Label-8mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 16 mg

NDC 62559-642-30
ATACAND® (candesartan cilexetil) Tablets
16 mg
Rx only
30 Tablets

Label-16mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 32 mg

NDC 62559-643-30
ATACAND® (candesartan cilexetil) Tablets
32 mg
Rx only
30 Tablets

Label-32mg
(click image for full-size original)

ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-640
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 4 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND (circular biconvex-shaped) Size 7mm
Flavor Imprint Code ACF;004
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-640-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 10/01/2018
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 8 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color PINK (light pink) Score 2 pieces
Shape ROUND (circular biconvex-shaped) Size 7mm
Flavor Imprint Code ACG;008
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-641-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 10/01/2018
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-642
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 16 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND (circular biconvex-shaped) Size 7mm
Flavor Imprint Code ACH;016
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-642-30 30 TABLET in 1 BOTTLE None
2 NDC:62559-642-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 10/01/2018
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-643
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 32 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND (circular; biconvex-shaped) Size 10mm
Flavor Imprint Code ACL;032
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-643-30 30 TABLET in 1 BOTTLE None
2 NDC:62559-643-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 10/01/2018
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 06/2020 ANI Pharmaceuticals, Inc.

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