NDC Code(s) : 0078-0521-15, 0078-0521-34, 0078-0521-61, 0078-0521-35, 0078-0522-15, 0078-0522-34, 0078-0522-61, 0078-0522-35, 0078-0523-15, 0078-0523-34, 0078-0523-61, 0078-0523-35, 0078-0524-15, 0078-0524-34, 0078-0524-61, 0078-0524-35
Packager : Novartis Pharmaceuticals Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0521
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029)
(ALISKIREN - UNII:502FWN4Q32) 		ALISKIREN150 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, WHEAT(UNII: 79QS2MG2LP)
Product Characteristics
Color WHITE Score no score
Shape OVAL (biconvex ovaloid) Size 15 mm
Flavor Imprint Code NVR;LCI
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-0521-1530 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
2NDC:0078-0521-3490 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
3NDC:0078-0521-35100 in 1 PACKAGE 01/08/2008
3NDC:0078-0521-611 in 1 BLISTER PACK Type 0: Not a Combination Product01/08/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022107 08/01/2008 01/31/2018
Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0522
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029)
(ALISKIREN - UNII:502FWN4Q32) 		ALISKIREN150 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, WHEAT(UNII: 79QS2MG2LP)
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code NVR;CLL
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-0522-1530 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
2NDC:0078-0522-3490 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
3NDC:0078-0522-35100 in 1 PACKAGE 01/08/2008
3NDC:0078-0522-611 in 1 BLISTER PACK Type 0: Not a Combination Product01/08/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022107 08/01/2008 01/31/2018
Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0523
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029)
(ALISKIREN - UNII:502FWN4Q32) 		ALISKIREN300 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, WHEAT(UNII: 79QS2MG2LP)
Product Characteristics
Color WHITE (violet white) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code NVR;CVI
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-0523-1530 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
2NDC:0078-0523-3490 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
3NDC:0078-0523-35100 in 1 PACKAGE 01/08/2008
3NDC:0078-0523-611 in 1 BLISTER PACK Type 0: Not a Combination Product01/08/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022107 08/01/2008 01/31/2018
Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0524
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029)
(ALISKIREN - UNII:502FWN4Q32) 		ALISKIREN300 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, WHEAT(UNII: 79QS2MG2LP)
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code NVR;CVV
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-0524-1530 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
2NDC:0078-0524-3490 in 1 BOTTLE Type 0: Not a Combination Product01/08/2008
3NDC:0078-0524-35100 in 1 PACKAGE 01/08/2008
3NDC:0078-0524-611 in 1 BLISTER PACK Type 0: Not a Combination Product01/08/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022107 08/01/2008 01/31/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 150 mg / 1 2 . 5 mg

Rx Only             NDC 0078-0521-15

Tekturna HCT®

(aliskiren and hydrochlorothiazide)

30 Tablets

150 mg/ 12.5 mg

PRINCIPAL DISPLAY PANEL Package Label – 150 mg / 12.5 mg

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 15 0 mg / 25 mg

Rx Only             NDC 0078-0522-15

Tekturna HCT®

(aliskiren and hydrochlorothiazide)

30 Tablets

150 mg/ 25 mg

PRINCIPAL DISPLAY PANEL Package Label – 150 mg / 25 mg

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 300 mg / 1 2 . 5 mg

Rx Only             NDC 0078-0523-15

Tekturna HCT®

(aliskiren and hydrochlorothiazide)

30 Tablets

300 mg/ 12.5 mg

PRINCIPAL DISPLAY PANEL Package Label – 300 mg / 12.5 mg

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 300 mg / 25 mg

Rx Only             NDC 0078-0524-15

Tekturna HCT®

(aliskiren and hydrochlorothiazide)

30 Tablets

300 mg/ 25 mg

PRINCIPAL DISPLAY PANEL Package Label – 300 mg / 25 mg