VALGANCICLOVIR HYDROCHLORIDE (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 450 mg (60 Tablets Bottle)

NDC 65862-753-60
Rx only
Valganciclovir
Tablets USP
450 mg
DO NOT BREAK OR CRUSH TABLETS
AUROBINDO 60 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 450 mg (60 Tablets Bottle)
(click image for full-size original)
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-753
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALGANCICLOVIR HYDROCHLORIDE (GANCICLOVIR) VALGANCICLOVIR 450 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape OVAL (biconvex) Size 17mm
Flavor Imprint Code H;96
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-753-60 60 TABLET in 1 BOTTLE None
2 NDC:65862-753-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-753-18 180 TABLET in 1 BOTTLE None
4 NDC:65862-753-05 500 TABLET in 1 BOTTLE None
5 NDC:65862-753-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204750 03/31/2016
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-753), MANUFACTURE (65862-753)

Revised: 07/2022 Aurobindo Pharma Limited

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