Amlodipine, Valsartan and Hydrochlorothiazide (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amlodipine, Valsartan and Hydrochlorothiazide Tablets

Rx Only

5 mg/160 mg/12.5 mg

NDC 68180-771-06

30 Tablets

Amlodipine, Valsartan and Hydrochlorothiazide Tablets
Rx Only
5 mg/160 mg/12.5 mg
NDC 68180-771-06
							30 Tablets
(click image for full-size original)

Amlodipine, Valsartan and Hydrochlorothiazide Tablets

Rx Only

10 mg/160 mg/12.5 mg

NDC 68180-772-06

30 Tablets

Amlodipine, Valsartan and Hydrochlorothiazide Tablets
Rx Only
10 mg/160 mg/12.5 mg
NDC 68180-772-06
							30 Tablets
(click image for full-size original)

Amlodipine, Valsartan and Hydrochlorothiazide Tablets

Rx Only

5 mg/160 mg/25 mg

NDC 68180-773-06

30 Tablets

Amlodipine, Valsartan and Hydrochlorothiazide Tablets
Rx Only
5 mg/160 mg/25 mg
NDC 68180-773-06
							30 Tablets
(click image for full-size original)

Amlodipine, Valsartan and Hydrochlorothiazide Tablets

Rx Only

10 mg/160 mg/25 mg

NDC 68180-774-06

30 Tablets

Amlodipine, Valsartan and Hydrochlorothiazide Tablets
Rx Only
10 mg/160 mg/25 mg
NDC 68180-774-06
							30 Tablets
(click image for full-size original)

Amlodipine, Valsartan and Hydrochlorothiazide Tablets

Rx Only

10 mg/320 mg/25 mg

NDC 68180-775-06

30 Tablets

Amlodipine, Valsartan and Hydrochlorothiazide Tablets
Rx Only
10 mg/320 mg/25 mg
NDC 68180-775-06
							30 Tablets
(click image for full-size original)
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine, valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-771
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
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LU;W41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-771-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-771-02 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-771-09 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200797 06/03/2015
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine, valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-772
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
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Mustard) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LU;W43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-772-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-772-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-772-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200797 06/03/2015
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine, valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-773
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
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LU;W42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-773-09 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-773-06 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-773-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200797 06/03/2015
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine, valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-774
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
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (Beige) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LU;W44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-774-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-774-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-774-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200797 06/03/2015
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine, valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-775
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
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE RED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color RED (Light brick red) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LU;W45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-775-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-775-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-775-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200797 06/03/2015
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 manufacture (57297-771), manufacture (57297-772), manufacture (57297-773), manufacture (57297-774), manufacture (57297-775), pack (57297-771), pack (57297-772), pack (57297-773), pack (57297-774), pack (57297-775)

Revised: 02/2016 LUPIN LIMITED

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