ATACAND (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

No. 3782 — Tablets ATACAND, 4 mg, are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other. They are supplied as follows:

Bottles of 30 NDC 54868-5591-0

No. 3780 — Tablets ATACAND, 8 mg, are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other. They are supplied as follows:

Bottles of 30 NDC 54868-5489-0

No. 3781 — Tablets ATACAND, 16 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other. They are supplied as follows:

Bottles of 30 NDC 54868-4413-0

No. 3791 — Tablets ATACAND, 32 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other. They are supplied as follows:

Bottles of 30 NDC 54868-4612-0

Storage

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

17 PATIENT COUNSELING INFORMATION

Pregnancy – Female patients of childbearing age should be told about the consequences of second- and third-trimester exposure to drugs that act on the renin-angiotensin system, and they should also be told that these consequences do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

Post-menarche adolescents should be questioned on a regular basis as to changes in menstrual pattern and the possibility of pregnancy.

Manufactured under the license

from Takeda Pharmaceutical Company, Ltd.

by: AstraZeneca AB, S-151 85 Södertälje, Sweden

for: AstraZeneca LP, Wilmington, DE 19850

ATACAND is a trademark of the AstraZeneca group of companies.

Rev. 04/11

©AstraZeneca 2009

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 4 mg package label
(click image for full-size original)
image of 8 mg package label
(click image for full-size original)
Atacand 16mg -- 30 tablet count bottle label
(click image for full-size original)
image of 32 mg package label
(click image for full-size original)
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5591(NDC:0186-0004)
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
POLYETHYLENE GLYCOLS
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
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:54868-5591-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 05/16/2006 06/30/2011
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5489(NDC:0186-0008)
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
POLYETHYLENE GLYCOLS
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
Product Characteristics
Color PINK ( light pink) Score 2 pieces
Shape ROUND (circular biconvex-sharped) Size 7mm
Flavor Imprint Code ACG;008
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5489-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 05/01/2006 06/30/2011
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4413(NDC:0186-0016)
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
POLYETHYLENE GLYCOLS
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
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:54868-4413-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 11/21/2000
ATACAND candesartan cilexetil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4612(NDC:0186-0032)
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
POLYETHYLENE GLYCOLS
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
CARBOXYMETHYLCELLULOSE CALCIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
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:54868-4612-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020838 04/17/2002 06/30/2013
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack (54868-5591), repack (54868-5489), repack (54868-4612), relabel (54868-4413), repack (54868-4413)

Revised: 08/2013 Physicians Total Care, Inc.

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