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)

label 1
(click image for full-size original)

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)

label 2
(click image for full-size original)

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)

label 3
(click image for full-size original)

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)

label 4
(click image for full-size original)
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

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