Valacyclovir (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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VALACYCLOVIR valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3135(NDC:31722-705)
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code I;87
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-3135-1 21 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68071-3135-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203047 05/25/2015
Labeler — NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals, Inc. 010632300 repack (68071-3135)

Revised: 08/2017 NuCare Pharmaceuticals, Inc.

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