NDC Code(s) : 72819-181-03, 72819-182-09, 72819-183-09, 72819-184-09
Packager : Archis Pharma LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Valsartanvalsartan TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72819-181
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code S026
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72819-181-0330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 09/01/2022
Valsartanvalsartan TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72819-182
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
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CROSPOVIDONE(UNII: 2S7830E561)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code S023
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72819-182-0990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 09/01/2022
Valsartanvalsartan TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72819-183
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code S024
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72819-183-0990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 09/01/2022
Valsartanvalsartan TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72819-184
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color brown Score no score
Shape OVAL Size 21 mm
Flavor Imprint Code S025
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72819-184-0990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 09/01/2022

LABELER - Archis Pharma LLC(026836212)

REGISTRANT - Square Pharmaceuticals Ltd.(731487153)

Establishment
Name Address ID/FEI Business Operations
Square Pharmaceuticals Ltd. 850366520 manufacture(72819-181, 72819-182, 72819-183, 72819-184)

PRINCIPAL DISPLAY PANEL

NDC 72819-181-03

Valsartan
Tablets, USP
40 mg

Rx only     30 Tablets

Each tablet contains:
Valsartan, USP 40 mg

Usual Dosage: See packaging insert

for complete dosaging instruction.

Dispense in tight container

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

Storage condition: Store at 25 oC (77 oF).

excursion permitted 15 oC TO 30 oC (59 oF TO 86 oF)

[See USP controlled room temperature]

Protect from moisture.

Made by:

Square Pharmaceuticals Ltd.
Bangladesh.

Mfg. Lic. No.: 235 & 460

Distributed by:

Archis Pharma LLC
15 Corporate Place South, Suite 108
Piscataway, NJ 08854, U.S.A.

Valsartan Tablets, USP 40 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 72819-182-09

Valsartan
Tablets, USP
80 mg

Rx only     90 Tablets

Each tablet contains:
Valsartan, USP 80 mg

Usual Dosage: See packaging insert

for complete dosaging instruction.

Dispense in tight container

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

Storage condition: Store at 25 oC (77 oF).

excursion permitted 15 oC TO 30 oC (59 oF TO 86 oF)

[See USP controlled room temperature]

Protect from moisture.

Distributed by:

Archis Pharma LLC
15 Corporate Place South, Suite 108
Piscataway, NJ 08854, U.S.A. Valsartan Tablets, USP 80 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 72819-183-09

Valsartan
Tablets, USP
160 mg

Rx only     90 Tablets

Each tablet contains:
Valsartan, USP 160 mg

Usual Dosage: See packaging insert

for complete dosaging instruction.

Dispense in tight container

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

Storage condition: Store at 25 oC (77 oF).

excursion permitted 15 oC TO 30 oC (59 oF TO 86 oF)

[See USP controlled room temperature]

Protect from moisture.

Distributed by:

Archis Pharma LLC
15 Corporate Place South, Suite 108
Piscataway, NJ 08854, U.S.A.

Made by: Square Pharmaceuticals Ltd.

Bangladesh.

Mfg. Lic. No.: 235 & 460

Valsartan Tablets, USP 160 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 72819-184-09

Valsartan
Tablets, USP
320 mg

Rx only 90 Tablets

Each tablet contains:
Valsartan, USP 320 mg

Usual Dosage: See packaging insert

for complete dosaging instruction.

Dispense in tight container

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

Storage condition: Store at 25 oC (77 oF).

excursion permitted 15 oC TO 30 oC (59 oF TO 86 oF)

[See USP controlled room temperature]

Protect from moisture

Distributed by:

Archis Pharma LLC
15 Corporate Place South, Suite 108
Piscataway, NJ 08854, U.S.A.

Made by: Square Pharmaceuticals Ltd.

Bangladesh.

Mfg. Lic. No.: 235 & 460

Valsartan Tablets, USP 320 mg Bottle Label