Prescription Drug Information: Amlodipine and Valsartan (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg/160 mg

Amlodipine and Valsartan Tablets, USP 5 mg/160 mg (30 Tablets in 1 Bottle)
Each tablet contains 6.9 mg of amlodipine besylate USP equivalent to 5 mg of amlodipine and 160 mg of valsartan USP46708-458-30

30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg/160 mg

Amlodipine and Valsartan Tablets, USP 10 mg/160 mg (30 Tablets in 1 Bottle)

Each tablet contains 13.9 mg of amlodipine besylate USP equivalent to 10 mg of amlodipine and 160 mg of valsartan USP
46708-459-30

30's bottle label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg/320 mg

Amlodipine and Valsartan Tablets, USP 5 mg/320 mg (30 Tablets in 1 Bottle)

Each tablet contains 6.9 mg of amlodipine besylate USP equivalent to 5 mg of amlodipine and 320 mg of valsartan USP

46708-460-30

30's bottle label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg/320 mg

Amlodipine and Valsartan Tablets, USP 10 mg/320 mg (30 Tablets in 1 Bottle)

Each tablet contains 13.9 mg of amlodipine besylate USP equivalent to 10 mg of amlodipine and 320 mg of valsartan USP

46708-461-30

30's bottle pack
(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:46708-458
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (DARK YELLOW) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code L298
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-458-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-458-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-458-71 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-458-10 100 TABLET, FILM COATED in 1 CARTON None
5 NDC:46708-458-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202713 12/01/2016
AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-459
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code L300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-459-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-459-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-459-71 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-459-10 100 TABLET, FILM COATED in 1 CARTON None
5 NDC:46708-459-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202713 12/01/2016
AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-460
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (DARK YELLOW) Score no score
Shape OVAL Size 21mm
Flavor Imprint Code L299
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-460-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-460-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-460-71 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-460-10 100 TABLET, FILM COATED in 1 CARTON None
5 NDC:46708-460-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202713 12/01/2016
AMLODIPINE AND VALSARTAN amlodipine and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-461
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape OVAL Size 21mm
Flavor Imprint Code L301
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-461-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-461-31 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-461-71 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-461-10 100 TABLET, FILM COATED in 1 CARTON None
5 NDC:46708-461-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202713 12/01/2016
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-458), MANUFACTURE (46708-459), MANUFACTURE (46708-460), MANUFACTURE (46708-461)

Revised: 09/2019 Alembic Pharmaceuticals Limited

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