Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-788-15
Valacyclovir Tablets, USP
500 mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026878815
NDC 50268-788-15
Valacyclovir Tablets, USP
500 mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026878815

PHARMACIST: Dispense the patient information leaflet with the drug product.
Each film-coated tablet contains: Valacyclovir hydrochloride USP (hydrous) equivalent to valacyclovir 500 mg.

Usual Dosage: See prescribing information for Dosage and Administration.
Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE
Mfg. Rev. P1409278 AV 09/14 (P)

label 1
(click image for full-size original)

NDC 50268-789-15
Valacyclovir Tablets, USP
1 gram
Rx Only
50 Tablets (5 X 10) Unit Dose
5026878915
NDC 50268-789-15
Valacyclovir Tablets, USP
1 gram
Rx Only
50 Tablets (5 X 10) Unit Dose
5026878915

PHARMACIST: Dispense the patient information leaflet with the drug product.
Each film-coated tablet contains: Valacyclovir hydrochloride USP (hydrous) equivalent to valacyclovir 1 gram.

Usual Dosage: See prescribing information for Dosage and Administration.
Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE Mfg. Rev. P1409281 AV 09/14 (P)

label 2
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-788(NDC:65862-448)
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
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 no score
Shape CAPSULE Size 18mm
Flavor Imprint Code F;82
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-788-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-788-11)
1 NDC:50268-788-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-788-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 09/22/2014
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-789(NDC:65862-449)
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:50268-789-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-789-11)
1 NDC:50268-789-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-789-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 09/22/2014
Labeler — AvPAK (832926666)

Revised: 05/2022 AvPAK

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