NDC Code(s) : 51079-192-01, 51079-192-03, 51079-193-01, 51079-193-03, 51079-194-01, 51079-194-03
Packager : Mylan Institutional Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-192(NDC:0378-6321)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN80 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color orange Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code M;V21
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-192-0330 in 1 BOX, UNIT-DOSE 08/03/2013
1NDC:51079-192-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078020 03/08/2013 07/31/2016
Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-193(NDC:0378-6322)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN160 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Color orange Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code M;V22
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-193-0330 in 1 BOX, UNIT-DOSE 08/03/2013
1NDC:51079-193-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078020 03/08/2013 08/31/2016
Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-194(NDC:0378-6323)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN160 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color orange Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code M;V23
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-194-0330 in 1 BOX, UNIT-DOSE 08/03/2013
1NDC:51079-194-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078020 03/08/2013 08/31/2016

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 80 mg/ 12.5 mg

NDC 51079-192-03

Valsartan and
Hydrochlorothiazide
Tablets, USP
80 mg/12.5 mg

30 Tablets (3 x 10)

Each film-coated tablet contains:
Valsartan, USP          80 mg
Hydrochlorothiazide, USP 12.5 mg

Usual Dosage: See accompanying
prescribing information and
Patient Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light, moisture and heat.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-11365 R1

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Valsartan and HCTZ 80 mg/12.5 mg Tablets Unit Carton LabelValsartan and HCTZ 80 mg/12.5 mg Tablets Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 160 mg/ 12.5 mg

NDC 51079-193-03

Valsartan and
Hydrochlorothiazide
Tablets, USP
160 mg/12.5 mg

30 Tablets (3 x 10)

Each film-coated tablet contains:
Valsartan, USP           160 mg
Hydrochlorothiazide, USP 12.5 mg

Usual Dosage: See accompanying
prescribing information and
Patient Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light, moisture and heat.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-11366 R1

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Valsartan and HCTZ 160 mg/12.5 mg Tablets Unit Carton LabelValsartan and HCTZ 160 mg/12.5 mg Tablets Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 160 mg/ 25 mg

NDC 51079-194-03

Valsartan and
Hydrochlorothiazide
Tablets, USP
160 mg/25 mg

30 Tablets (3 x 10)

Each film-coated tablet contains:
Valsartan, USP          160 mg
Hydrochlorothiazide, USP 25 mg

Usual Dosage: See accompanying
prescribing information and
Patient Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light, moisture and heat.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-11367 R1

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Valsartan and HCTZ 160 mg/25 mg Tablets Unit Carton LabelValsartan and HCTZ 160 mg/25 mg Tablets Unit Carton Label