Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500mg 30s
(click image for full-size original)

1gram 30s
(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 (1600000 WAMW)
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
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:45963-558-04 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:45963-558-08 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:45963-558-30 30 TABLET, FILM COATED 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 (1600000 WAMW)
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
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 in 1 BOTTLE None
2 NDC:45963-559-08 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:45963-559-30 30 TABLET, FILM COATED 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 Pharma, Inc. (119723554)

Revised: 12/2017 Actavis Pharma, Inc.

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