Amlodipine and Valsartan (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/160 mg (30 Tablets Bottle)

NDC 65862-737-30
Rx only
Amlodipine and Valsartan Tablets USP
5 mg / 160 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg/160 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/160 mg Blister Carton (3 x 10 Unit-dose)

NDC 65862-737-03
Rx only
Amlodipine and Valsartan Tablets USP
5 mg / 160 mg
AUROBINDO 30 (3 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg/160 mg Blister Carton (3 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/160 mg (30 Tablets Bottle)

NDC 65862-739-30
Rx only
Amlodipine and Valsartan Tablets USP
10 mg / 160 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg/160 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/160 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/160 mg Blister Carton (3 x 10 Unit-dose)

NDC 65862-739-03
Rx only
Amlodipine and Valsartan Tablets USP
10 mg / 160 mg
AUROBINDO 30 (3 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg/160 mg Blister Carton (3 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/160 mg Blister Carton (3 x 10 Unit-dose)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/320 mg (30 Tablets Bottle)

NDC 65862-738-30
Rx only
Amlodipine and Valsartan Tablets USP
5 mg / 320 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg/320 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/320 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/320 mg Blister Carton (3 x 10 Unit-dose)

NDC 65862-738-03
Rx only
Amlodipine and Valsartan Tablets USP
5 mg / 320 mg
AUROBINDO 30 (3 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg/320 mg Blister Carton (3 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/320 mg (30 Tablets Bottle)

NDC 65862-740-30
Rx only
Amlodipine and Valsartan Tablets USP
10 mg / 320 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg/320 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/320 mg Blister Carton (3 x 10 Unit-dose)

NDC 65862-740-03
Rx only
Amlodipine and Valsartan Tablets USP
10 mg / 320 mg
AUROBINDO 30 (3 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg/320 mg Blister Carton (3 x 10 Unit-dose)
(click image for full-size original)

AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-737
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape OVAL (biconvex) Size 18mm
Flavor Imprint Code L;35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-737-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-737-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-737-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-737-10)
3 NDC:65862-737-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-737-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206512 04/22/2016
AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-739
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Light Yellow) Score no score
Shape OVAL (biconvex) Size 18mm
Flavor Imprint Code L;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-739-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-739-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-739-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-739-10)
3 NDC:65862-739-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-739-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206512 04/22/2016
AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-738
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Dark Yellow) Score no score
Shape OVAL (biconvex) Size 22mm
Flavor Imprint Code L;37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-738-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-738-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-738-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-738-10)
3 NDC:65862-738-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-738-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206512 04/22/2016
AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-740
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape OVAL (biconvex) Size 22mm
Flavor Imprint Code L;38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-740-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-740-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-740-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-740-10)
3 NDC:65862-740-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-740-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206512 04/22/2016
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-737), ANALYSIS (65862-738), ANALYSIS (65862-739), ANALYSIS (65862-740), MANUFACTURE (65862-737), MANUFACTURE (65862-738), MANUFACTURE (65862-739), MANUFACTURE (65862-740)

Revised: 11/2019 Aurobindo Pharma Limited

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