Valsartan (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-783-15
Valsartan Tablets, USP
40 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026878315
NDC 50268-783-15
Valsartan Tablets, USP
40 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026878315

Attention: Dispense with patient information sheet.
Each film coated tablet contains 40 mg of Valsartan, USP.
USUAL DOSAGE: See package insert.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
Keep this and all drugs out of the reach of children.
Contact Number: 1-855-361-3993

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT of AvKARE
Mfg. Rev. 2009 AV 04/16 (P)

NDC 50268-784-15
Valsartan Tablets, USP
80 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026878415
NDC 50268-784-15
Valsartan Tablets, USP
80 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026878415

Attention: Dispense with patient information sheet.
Each film coated tablet contains 80 mg of Valsartan, USP.
USUAL DOSAGE: See package insert.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
Keep this and all drugs out of the reach of children.
Contact Number: 1-855-361-3993

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT of AvKARE Mfg. Rev. 2009 AV 04/16 (P)

NDC 50268-785-15
Valsartan Tablets, USP
160 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026878515
NDC 50268-785-15
Valsartan Tablets, USP
160 mg
Rx Only
50 Tablets (5 x 10) Unit Dose
5026878515

Attention: Dispense with patient information sheet.
Each film coated tablet contains 160 mg of Valsartan, USP.
USUAL DOSAGE: See package insert.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
Keep this and all drugs out of the reach of children.
Contact Number: 1-855-361-3993

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT of AvKARE Mfg. Rev. 2009 AV 04/16 (P)

NDC 50268-786-13
Valsartan Tablets, USP
320 mg
Rx Only
30 Tablets (3 x 10) Unit Dose
5026878613
NDC 50268-786-13
Valsartan Tablets, USP
320 mg
Rx Only
30 Tablets (3 x 10) Unit Dose
5026878613

Attention: Dispense with patient information sheet.
Each film coated tablet contains 320 mg of Valsartan, USP.
USUAL DOSAGE: See package insert.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
Keep this and all drugs out of the reach of children.
Contact Number: 1-855-361-3993

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT of AvKARE Mfg. Rev. 2009 AV 04/16 (P)

VALSARTAN valsartan tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-783(NDC:31722-745) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 40 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POVIDONE TITANIUM DIOXIDE FERRIC OXIDE YELLOW POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color yellow Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code H;182 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50268-783-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-783-11) 1 NDC:50268-783-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-783-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203311 06/29/2016

VALSARTAN valsartan tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-784(NDC:31722-746) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 80 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POVIDONE TITANIUM DIOXIDE FERRIC OXIDE RED POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color pink Score no score Shape ROUND Size 9mm Flavor Imprint Code H;183 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50268-784-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-784-11) 1 NDC:50268-784-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-784-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203311 06/29/2016

VALSARTAN valsartan tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-785(NDC:31722-747) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 160 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POVIDONE TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color yellow (Yellowish brown) Score no score Shape OVAL Size 16mm Flavor Imprint Code H;184 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50268-785-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-785-11) 1 NDC:50268-785-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-785-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203311 06/29/2016

VALSARTAN valsartan tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-786(NDC:31722-748) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 320 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POVIDONE TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color gray (dark grey-violet) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code H;185 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50268-786-13 30 BLISTER PACK in 1 BOTTLE, UNIT-DOSE contains a BLISTER PACK (50268-786-11) 1 NDC:50268-786-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOTTLE, UNIT-DOSE (50268-786-13)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203311 06/29/2016

Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK