NDC Code(s) : 60505-3758-9, 60505-3758-5, 60505-3759-9, 60505-3759-5, 60505-3760-9
Packager : Apotex Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL16 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
Hydroxypropyl Cellulose (Type H)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape CAPSULE (shaped) Size 10 mm
Flavor Imprint Code APO;16;12;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-3758-990 in 1 BOTTLE Type 0: Not a Combination Product12/04/2012
2NDC:60505-3758-5500 in 1 BOTTLE Type 0: Not a Combination Product12/04/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202884 12/04/2012
Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL32 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
Hydroxypropyl Cellulose (Type H)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE (shaped) Size 11 mm
Flavor Imprint Code APO;32;12;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-3759-990 in 1 BOTTLE Type 0: Not a Combination Product12/04/2012
2NDC:60505-3759-5500 in 1 BOTTLE Type 0: Not a Combination Product12/04/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202884 12/04/2012
Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3760
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL32 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
Hydroxypropyl Cellulose (Type H)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Ferric Oxide Red(UNII: 1K09F3G675)
Product Characteristics
Color PINK (pink to light-pink) Score 2 pieces
Shape CAPSULE (shaped) Size 11 mm
Flavor Imprint Code APO;32;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-3760-990 in 1 BOTTLE Type 0: Not a Combination Product06/03/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202884 06/03/2013

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-3758-9

Candesartan and hydrochlorothiazide Tablets

16 mg/12.5 mg

Rx only

90 tablets

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-3759-9

Candesartan and hydrochlorothiazide Tablets

32 mg/12.5 mg

Rx only

90 tablets

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-3760-9

Candesartan and hydrochlorothiazide Tablets

32 mg/25 mg

Rx only

90 tablets