NDC Code(s) : 68258-6969-9
Packager : Dispensing Solutions, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Valsartan and HydrochlorothiazideValsartan and Hydrochlorothiazide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-6969(NDC:68180-102)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I) 		VALSARTAN320 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code LU;P15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68258-6969-990 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078946 03/21/2013

LABELER - Dispensing Solutions, Inc.(066070785)

REGISTRANT - PSS World Medical, Inc.(101822682)

Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 relabel(68258-6969), repack(68258-6969)

PRINCIPAL DISPLAY PANEL

NDC 68258-6969-09

NDC 68258-6969-09