Valganciclovir (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 69097-277-03

Valganciclovir Tablets, USP 450 mg

DO NOT BREAK OR CRUSH TABLETS

CAUTION: Strict adherence

to dosage recommendation is

essential to avoid overdose.

60 Tablets

Cipla

Valganciclovir Tablets, USP 450mg label 60s CiplaUSA
(click image for full-size original)
VALGANCICLOVIR valganciclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-277
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALGANCICLOVIR HYDROCHLORIDE (GANCICLOVIR) VALGANCICLOVIR HYDROCHLORIDE 450 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE (15 MPA.S AT 5%)
STEARIC ACID
HYPROMELLOSE 2910 (15 MPA.S)
POVIDONE K30
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape CAPSULE ((Biconvex)) Size 17mm
Flavor Imprint Code C277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-277-03 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209672 11/12/2018
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Cipla Kurkumbh 917066446 API MANUFACTURE (69097-277), MANUFACTURE (69097-277)
Establishment
Name Address ID/FEI Operations
Cipla Patalganga 916940208 MANUFACTURE (69097-277)

Revised: 11/2018 Cipla USA Inc.

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