Valacyclovir Hydrochloride (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500mg 30s label
(click image for full-size original)
1gram 21s label
(click image for full-size original)

VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-558
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape OVAL (biconvex) Size 17mm
Flavor Imprint Code V;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-558-11 10 BLISTER PACK (10 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 10 TABLET, FILM COATED (10 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (45963-558-11)
2 NDC:45963-558-04 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE None
3 NDC:45963-558-08 90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
4 NDC:45963-558-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090370 04/25/2011
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-559
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
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (biconvex) Size 17mm
Flavor Imprint Code V;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-559-04 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE None
2 NDC:45963-559-08 90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
3 NDC:45963-559-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
4 NDC:45963-559-31 21 TABLET, FILM COATED (21 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090370 04/25/2011
Labeler — Actavis Inc. (099262404)
Establishment
Name Address ID/FEI Operations
Actavis Elizabeth LLC 623114928 LABEL (45963-558), LABEL (45963-559), PACK (45963-558), PACK (45963-559)
Establishment
Name Address ID/FEI Operations
Actavis LLC 017665256 LABEL (45963-558), LABEL (45963-559), PACK (45963-558), PACK (45963-559)
Establishment
Name Address ID/FEI Operations
Vivimed Labs (alathur) Private Limited 650341238 MANUFACTURE (45963-558), MANUFACTURE (45963-559)

Revised: 11/2013 Actavis Inc.

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