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)

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 — 1 gram (100 Tablet Bottle)

NDC 65862-449-01

Rx only
Valacyclovir Tablets, USP
1 gramAUROBINDO 100 Tablets

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