Valsartan and Hydrochlorothiazide (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 71205-004-90

Valsartan and Hydrochlorothiazide Tablets, USP

320 mg/12.5 mg

PHARMACIST: Dispense the Patient Information Leaflet provided separately to each patient.

90 Tablets
Rx Only

71205-004-90
(click image for full-size original)
VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-004(NDC:0591-2318)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (90000 WAMW)
SILICON DIOXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 4000
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape OVAL Size 18mm
Flavor Imprint Code VH4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-004-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71205-004-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:71205-004-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091519 03/21/2013
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-004), RELABEL (71205-004)

Revised: 01/2021 Proficient Rx LP

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