Valsartan and Hydrochlorothiazide (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

Package Label – 80 mg /12.5 mg

Rx Only NDC 60505-3806-9

valsartan and hydrochlorothiazide, USP

80 mg/12.5 mg

90 tablets

Dosage: See package insert

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from moisture.

Dispense in tight container (USP).

Please see accompanying full Prescribing Information.

80-12-5-90-bottle-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 160 mg /12.5 mg

Rx Only NDC 60505-3807-9

valsartan and hydrochlorothiazide, USP

160 mg/12.5 mg per tablet

90 tablets

Dosage: See package insert

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from moisture.

Dispense in tight container (USP).

Please see accompanying full Prescribing Information.

160-12-5-90-bottle-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 160 mg /25 mg

Rx Only NDC 60505-3808-9

valsartan and hydrochlorothiazide, USP

160 mg/25 mg per tablet

90 tablets

Dosage: See package insert

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]

Protect from moisture.

Dispense in tight container (USP).

Please see accompanying full Prescribing Information.

160-25-90-bottle-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 320 mg /12.5 mg

Rx Only NDC 60505-3809-9

valsartan and hydrochlorothiazide, USP

320 mg/12.5 mg per tablet

90 tablets

Dosage: See package insert

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from moisture.

Dispense in tight container (USP).

Please see accompanying full Prescribing Information.

320-12-5-90-bottle-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 320 mg /25 mg

Rx Only NDC 60505-3810-9

valsartan and hydrochlorothiazide, USP

320 mg/25 mg per tablet

90 tablets

Dosage: See package insert

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from moisture.

Dispense in tight container (USP).

Please see accompanying full Prescribing Information.

320-25-90-bottle-label
(click image for full-size original)
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3806
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 80 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
POWDERED CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
Hydroxypropyl Cellulose (Type H)
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (Light orange) Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code APO;80;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3806-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-3806-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203026 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3807
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
POWDERED CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
Hydroxypropyl Cellulose (Type H)
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;160;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3807-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-3807-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203026 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3808
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
POWDERED CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
Hydroxypropyl Cellulose (Type H)
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERRIC OXIDE RED
Ferrosoferric Oxide
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;160;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3808-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-3808-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203026 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3809
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
POWDERED CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
Hydroxypropyl Cellulose (Type H)
TITANIUM DIOXIDE
FERRIC OXIDE RED
Ferrosoferric Oxide
Product Characteristics
Color PINK Score no score
Shape OVAL Size 17mm
Flavor Imprint Code APO;320;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3809-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-3809-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203026 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
POWDERED CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
Hydroxypropyl Cellulose (Type H)
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 17mm
Flavor Imprint Code APO;320;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3810-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-3810-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203026 03/21/2013
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Research Private Limited 862584104 manufacture (60505-3806), manufacture (60505-3807), manufacture (60505-3808), manufacture (60505-3809), manufacture (60505-3810), analysis (60505-3806), analysis (60505-3807), analysis (60505-3808), analysis (60505-3809), analysis (60505-3810)

Revised: 12/2017 Apotex Corp.

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