Valganciclovir (Page 9 of 9)

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contains drug product from Dr. Reddy’s Laboratories Limited as follows:
(450 mg / 30 UD) NDC 68084-965-25 packaged from NDC 55111-762

Distributed by:
American Health Packaging Columbus, OH 43217

8296525/0119

Package/Label Display Panel – Carton – 450 mg

450 mg Valganciclovir Tablets Carton
(click image for full-size original)

NDC 68084- 965 -25

Valganciclovir
Tablets, USP

450 mg

30 Tablets (5 x 6)               Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Film-Coated Tablet Contains:
Valganciclovir Hydrochloride USP equivalent to
Valganciclovir 450 mg.

DO NOT BREAK OR CRUSH TABLETS

Usual Dosage: See package insert for full prescribing
information.

CAUTION: Strict adherence to dosage
recommendations is essential to avoid overdose.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 55111-762, Dr. Reddy’s Laboratories Limited.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

096525 0296525/0119

Package/Label Display Panel – Blister – 450 mg

450 mg Valganciclovir Tablet Blister
(click image for full-size original)

Valganciclovir Tablet, USP

450 mg

VALGANCICLOVIR valganciclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-965(NDC:55111-762)
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 (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape OVAL Size 17mm
Flavor Imprint Code RDY;762
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-965-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-965-95)
1 NDC:68084-965-95 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-965-25)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203511 01/07/2015
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-965)

Revised: 08/2019 American Health Packaging

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