Valsartan (Page 7 of 7)

Package/Label Display Panel

Valsartan Tablets USP 80 mg
(click image for full-size original)

Valsartan Tablets USP 80 mg

NDC 54868-6458

VALSARTAN

Tablets USP

80 mg

PHARMACIST: PLEASE DISPENSE

WITH ATTACHED PATIENT

INFORMATION LEAFLET

Rx only

Physicians Total Care, Inc.

Package/Label Display Panel

Valsartan Tablets USP 160 mg
(click image for full-size original)

Valsartan Tablets USP 160 mg

NDC 54868-6452

VALSARTAN

Tablets USP

160 mg

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION LEAFLET

Rx only

Physicians Total Care, Inc.

Package/Label Display Panel

Valsartan Tablets USP 320 mg
(click image for full-size original)

Valsartan Tablets USP 320 mg

NDC 54868-6453

VALSARTAN

Tablets USP

320 mg

PHARMACIST: PLEASE DISPENSE WITH ATTACHED

PATIENT INFORMATION LEAFLET

Rx only

Physicians Total Care, Inc.

VALSARTAN
valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6458(NDC:0093-7432)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 7432;TV
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6458-0 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077530 01/05/2015
VALSARTAN
valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6452(NDC:0093-7433)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 7433;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6452-0 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077530 01/05/2015
VALSARTAN
valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6453(NDC:0093-7434)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 7434;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6453-0 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077530 01/05/2015
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-6458), repack (54868-6458), relabel (54868-6452), repack (54868-6452), relabel (54868-6453), repack (54868-6453)

Revised: 04/2015 Physicians Total Care, Inc.

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