NDC Code(s) : 43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
Packager : Solco Healthcare US, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Valsartanvalsartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-367
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE Size 8 mm
Flavor Imprint Code HH;341
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-367-0330 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
2NDC:43547-367-0990 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
3NDC:43547-367-50500 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
4NDC:43547-367-111000 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204821 08/31/2015
Valsartanvalsartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-368
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN80 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 11 mm
Flavor Imprint Code HH;342
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-368-0330 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
2NDC:43547-368-0990 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
3NDC:43547-368-50500 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
4NDC:43547-368-111000 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204821 08/31/2015
Valsartanvalsartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-369
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN160 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 13 mm
Flavor Imprint Code HH;343
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-369-0330 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
2NDC:43547-369-0990 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
3NDC:43547-369-50500 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
4NDC:43547-369-111000 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204821 08/31/2015
Valsartanvalsartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-370
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN320 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code HH;344
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-370-0330 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
2NDC:43547-370-0990 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
3NDC:43547-370-50500 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
4NDC:43547-370-111000 in 1 BOTTLE Type 0: Not a Combination Product31/08/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204821 08/31/2015

LABELER - Solco Healthcare US, LLC(828343017)

PRINCIPAL DISPLAY PANEL

Container Label-40 mg-30 scored tablets

Rx only

NDC 43547-367-03

Valsartan Tablets, USP

PHARMACIST: Dispense with the patient information sheet.

Each film-coated tablet contains:

Valsartan, USP……….40 mg

Usual dosage:

See packaging insert for complete dosing instructions.

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

Store tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in this tightly closed container, [See USP Controlled Room Temperature].

Protect from moisture.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 08/2020

201645-01

08/2021

40 mg 30 tablets

Container Label-80 mg-30 tablets

Rx only

NDC 43547-368-03

Valsartan Tablets, USP

PHARMACIST: Dispense with the patient information sheet.

Each film-coated tablet contains:

Valsartan, USP……….80 mg

Usual dosage:

See packaging insert for complete dosing instructions.

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

Store tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in this tightly closed container, [See USP Controlled Room Temperature].

Protect from moisture.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 08/2021

201638-01

08/2021

40 mg 30 tablets

Container Label-160 mg-30 tablets

Rx only

NDC 43547-369-03

Valsartan Tablets, USP

PHARMACIST: Dispense with the patient information sheet.

Each film-coated tablet contains:

Valsartan, USP……….160 mg

Usual dosage:

See packaging insert for complete dosing instructions.

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

Store tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in this tightly closed container, [See USP Controlled Room Temperature].

Protect from moisture.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 08/2021

201639-01

08/2021

40 mg 30 tablets

Container Label-320 mg-30 tablets

Rx only

NDC 43547-370-03

Valsartan Tablets, USP

PHARMACIST: Dispense with the patient information sheet.

Each film-coated tablet contains:

Valsartan, USP……….320 mg

Usual dosage:

See packaging insert for complete dosing instructions.

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

Store tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in this tightly closed container, [See USP Controlled Room Temperature].

Protect from moisture.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 08/2021

201640-01

08/2021

40 mg 30 tablets