Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Tablet Bottle)

NDC 65862-448-01
Rx only
Valacyclovir Tablets, USP
500 mg AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-448-10
Rx only
Valacyclovir Tablets, USP
500 mg
100 (10 blister cards
AUROBINDO each containing 10 tablets) Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 gram (100 Tablet Bottle)

NDC 65862-449-01

Rx only
Valacyclovir Tablets, USP
1 gramAUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1 gram (100 Tablet Bottle)
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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 (120 .MU.M)
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
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:65862-448-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-448-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-448-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-448-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-448-35 3500 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:65862-448-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-448-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 05/24/2010
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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 (120 .MU.M)
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
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:65862-449-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-449-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-449-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-449-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-449-15 1500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 05/24/2010
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 829084461 MANUFACTURE (65862-448)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650918514 ANALYSIS (65862-448), ANALYSIS (65862-449), MANUFACTURE (65862-448), MANUFACTURE (65862-449)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 078296263 RELABEL (65862-448), REPACK (65862-448), LABEL (65862-448), PACK (65862-448)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-448), ANALYSIS (65862-449), MANUFACTURE (65862-448), MANUFACTURE (65862-449)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-448), ANALYSIS (65862-449), MANUFACTURE (65862-448), MANUFACTURE (65862-449)

Revised: 02/2020 Aurobindo Pharma Limited

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