NDC Code(s) : 0591-3249-21, 0591-3249-30, 0591-3248-19, 0591-3248-21, 0591-3248-30, 0591-3248-42
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Valacyclovir HydrochlorideValacyclovir Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3249
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE(UNII: G447S0T1VC)
(ACYCLOVIR - UNII:X4HES1O11F) 		ACYCLOVIR1 g
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 21 mm
Flavor Imprint Code WPI;3249
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3249-2121 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/05/2010
2NDC:0591-3249-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/05/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077135 05/24/2010
Valacyclovir HydrochlorideValacyclovir Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3248
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE(UNII: G447S0T1VC)
(ACYCLOVIR - UNII:X4HES1O11F) 		ACYCLOVIR500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code WPI;3248
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3248-1990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/05/2010
2NDC:0591-3248-2121 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/05/2010
3NDC:0591-3248-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/05/2010
4NDC:0591-3248-4242 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/05/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077135 05/24/2010

PRINCIPAL DISPLAY PANEL

NDC 0591-3248-30
Valacyclovir Hydrochloride Tablets USP
500 mg*
PHARMACIST: Dispense the Patient Information Leaflet with the drug product
Watson® 30 Tablets 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 - 25ºC (68º - 77ºF). [See USP Controlled Room Temperature.]

Code No. GO/DRUGS/536

Manufactured By:
Cipla Ltd.
Verna Goa, INDIA

NDC 0591-3248-30 Valacyclovir Hydrochloride Tablets USP 500 mg*

PRINCIPAL DISPLAY PANEL

NDC 0591-3249-30
Valacyclovir Hydrochloride Tablets USP
1 gm*
PHARMACIST: Dispense the Patient Information
Leaflet with the drug product
Watson® 30 Tablets 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 - 25ºC (68º - 77ºF) [See USP Controlled Room Temperature].

Code No. GO/DRUGS/536

Manufactured By:
Cipla Ltd.
Verna Goa, INDIA

NDC 0591-3249-30 Valacyclovir Hydrochloride Tablets USP 1 gm*