Valacyclovir Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL


Valacyclovir
Hydrochloride
Tablets


500 mg*


PHARMACIST: Dispense the Patient Information
Leaflet with the drug product
Rx Only
*Each tablet contains:
Valacyclovir hydrochloride 556.22 mg
(equivalent to 500 mg of valacyclovir)
Usual Dosage: See package insert for Dosage and Administration.
Store at 20º — 25 º C (68 º — 77 º F). [See USP controlled room temperature.]

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL


Valacycl
ovir
Hydrochloride
Tablets


1 g m *


PHARMACIST: Dispense the Patient Information
Leaflet with the drug product
Rx Only
*Each tablet contains:
Valacyclovir hydrochloride 1.112 gm
(equivalent to 1 gm of valacyclovir)
Usual Dosage: See package insert for Dosage and Administration.
Store at 20º — 25 º C (68 º — 77 º F). [See USP controlled room temperature.]

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6089(NDC:0591-3249)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROGENATED CASTOR OIL
HYPROMELLOSES
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 21mm
Flavor Imprint Code WPI;3249
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6089-0 21 TABLET, FILM COATED (21 TABLET) in 1 BOTTLE None
2 NDC:54868-6089-1 3 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
3 NDC:54868-6089-2 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:54868-6089-3 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:54868-6089-4 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:54868-6089-5 5 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
7 NDC:54868-6089-6 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
8 NDC:54868-6089-7 4 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077135 06/11/2010
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6090(NDC:0591-3248)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYDROGENATED CASTOR OIL
HYPROMELLOSES
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code WPI;3248
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6090-0 20 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
2 NDC:54868-6090-1 10 TABLET, FILM COATED (21 TABLET) in 1 BOTTLE None
3 NDC:54868-6090-2 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
4 NDC:54868-6090-3 15 TABLET, FILM COATED (42 TABLET) in 1 BOTTLE None
5 NDC:54868-6090-4 21 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:54868-6090-5 40 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077135 12/03/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 01/2012 Physicians Total Care, Inc.

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