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

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.