Valsartan (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 40 mg

Rx Only

NDC 76483-026-04

Valsartan Tablets, USP

40 mg

100 Scored Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 80 mg

Rx Only

NDC 76483-023-04

Valsartan Tablets, USP

80 mg

100 Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 160 mg

Rx Only

NDC 76483-024-04

Valsartan Tablets, USP

160 mg

100 Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 320 mg

Rx Only

NDC 76483-025-04

Valsartan Tablets, USP

320 mg

100 Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 40 mg

Rx Only

NDC 76483-026-06

Valsartan Tablets, USP

40 mg

1000 Scored Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 80 mg

Rx Only

NDC 76483-023-06

Valsartan Tablets, USP

80 mg

1000 Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 160 mg

Rx Only

NDC 76483-024-06

Valsartan Tablets, USP

160 mg

1000 Tablets

Image
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 320 mg

Rx Only

NDC 76483-025-06

Valsartan Tablets, USP

320 mg

1000 Tablets

Image
(click image for full-size original)
VALSARTAN valsartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76483-026
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
Product Characteristics
Color YELLOW (Deep Yellow) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code S026
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76483-026-04 100 TABLET in 1 BOTTLE None
2 NDC:76483-026-06 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 06/30/2020
VALSARTAN valsartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76483-023
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 8000
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 4000
Product Characteristics
Color PINK Score no score
Shape TEAR (Almond Shaped) Size 10mm
Flavor Imprint Code S023
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76483-023-04 100 TABLET in 1 BOTTLE None
2 NDC:76483-023-06 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 06/30/2020
VALSARTAN valsartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76483-024
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
Product Characteristics
Color YELLOW Score no score
Shape TEAR (Almond Shaped) Size 13mm
Flavor Imprint Code S024
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76483-024-04 100 TABLET in 1 BOTTLE None
2 NDC:76483-024-06 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 06/30/2020
VALSARTAN valsartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76483-025
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 8000
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 4000
Product Characteristics
Color BROWN Score no score
Shape TEAR (Almond Shaped) Size 16mm
Flavor Imprint Code S025
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76483-025-04 100 TABLET in 1 BOTTLE None
2 NDC:76483-025-06 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205347 06/30/2020
Labeler — SQUARE PHARMACEUTICALS LIMITED (731487153)
Registrant — SQUARE PHARMACEUTICALS LIMITED (731487153)
Establishment
Name Address ID/FEI Operations
SQUARE PHARMACEUTICALS LIMITED 731487153 ANALYSIS (76483-026), ANALYSIS (76483-023), ANALYSIS (76483-024), ANALYSIS (76483-025), MANUFACTURE (76483-026), MANUFACTURE (76483-023), MANUFACTURE (76483-024), MANUFACTURE (76483-025), PACK (76483-026), PACK (76483-023), PACK (76483-024), PACK (76483-025), LABEL (76483-026), LABEL (76483-023), LABEL (76483-024), LABEL (76483-025)

Revised: 06/2019 SQUARE PHARMACEUTICALS LIMITED

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.