Valsartan and Hydrochlorothiazide (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 80 mg/12.5 mg (90 Tablets Bottle)

NDC 65862-547-90
Rx only
Valsartan and
Hydrochlorothiazide
Tablets, USP
80 mg/12.5 mg AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 80 mg/12.5 mg (90 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 80 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-547-10

Rx only
Valsartan and Hydrochlorothiazide Tablets, USP
80 mg/12.5 mg

AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 80 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 160 mg/12.5 mg (90 Tablets Bottle)

NDC 65862-548-90

Rx only
Valsartan and
Hydrochlorothiazide
Tablets, USP
160 mg/12.5 mg

AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 160 mg/12.5 mg (90 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 160 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-548-10 Rx only
Valsartan and Hydrochlorothiazide Tablets, USP
160 mg/12.5 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 160 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 160 mg/25 mg (90 Tablets Bottle)

NDC 65862-549-90

Rx only
Valsartan and
Hydrochlorothiazide
Tablets, USP
160 mg/25 mg
AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 160 mg/25 mg (90 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 160 mg/25 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-549-10 Rx only
Valsartan and Hydrochlorothiazide Tablets, USP
160 mg/25 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 160 mg/25 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 320 mg/12.5 mg (90 Tablets Bottle)

NDC 65862-550-90 Rx only
Valsartan and
Hydrochlorothiazide
Tablets, USP
320 mg/12.5 mg
AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 320 mg/12.5 mg (90 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 320 mg/25 mg (90 Tablets Bottle)

NDC 65862-551-90
Rx only
Valsartan and
Hydrochlorothiazide
Tablets, USP
320 mg/25 mg
AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 320 mg/25 mg (90 Tablets Bottle)
(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:65862-547
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 8000
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape OVAL (Ovaloid, Beveled Edge, Biconvex) Size 13mm
Flavor Imprint Code I;61
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-547-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-547-99 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-547-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-547-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202519 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-548
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 8000
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color RED (Dark Red) Score no score
Shape OVAL (Ovaloid, Beveled Edge, Biconvex) Size 18mm
Flavor Imprint Code I;62
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-548-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-548-99 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-548-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-548-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202519 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-549
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN (Brown-Orange) Score no score
Shape OVAL (Ovaloid, Beveled Edge, Biconvex) Size 18mm
Flavor Imprint Code I;63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-549-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-549-99 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-549-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-549-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202519 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-550
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK Score no score
Shape OVAL (Ovaloid, Beveled Edge, Biconvex) Size 22mm
Flavor Imprint Code I;64
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-550-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-550-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202519 03/21/2013
VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-551
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL (Ovaloid, Beveled Edge, Biconvex) Size 22mm
Flavor Imprint Code I;65
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-551-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-551-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202519 03/21/2013
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-547), ANALYSIS (65862-548), ANALYSIS (65862-549), ANALYSIS (65862-550), ANALYSIS (65862-551), MANUFACTURE (65862-547), MANUFACTURE (65862-548), MANUFACTURE (65862-549), MANUFACTURE (65862-550), MANUFACTURE (65862-551)

Revised: 09/2020 Aurobindo Pharma Limited

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