NDC Code(s) : 53217-054-30, 53217-054-60, 53217-054-90
Packager : Aidarex Pharmaceuticals LLC

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:53217-054(NDC:64679-152)
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K90(UNII: RDH86HJV5Z)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (blue) Score no score
Shape CAPSULE (capsule-shaped) Size 19 mm
Flavor Imprint Code W152
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53217-054-3030 in 1 BOTTLE, PLASTIC
2NDC:53217-054-6060 in 1 BOTTLE, PLASTIC
3NDC:53217-054-9090 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090216 05/24/2010

LABELER - Aidarex Pharmaceuticals LLC(801503249)

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