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

10 mg/160 mg/12.5 mg

NDC 68180-772-06

30 Tablets

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

10 mg/160 mg/25 mg

NDC 68180-774-06

30 Tablets

Amlodipine, Valsartan and Hydrochlorothiazide Tablets

Rx Only

10 mg/320 mg/25 mg

NDC 68180-775-06

30 Tablets

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