Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 gram (30 Tablets Bottle)

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VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1548(NDC:57237-043)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code F;8;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1548-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 05/24/2010
Labeler — NuCare Pharmacuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-1548)

Revised: 07/2017 NuCare Pharmacuticals,Inc.

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