NDC 53217-054-90
API & Excipient Details

Valacyclovir Hydrochloride marketed by Aidarex Pharmaceuticals LLC under NDC Code 53217-054-90

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALACYCLOVIR HYDROCHLORIDE(UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)	ACYCLOVIR	500 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53217-054-30	30 in 1 BOTTLE, PLASTIC
2	NDC:53217-054-60	60 in 1 BOTTLE, PLASTIC
3	NDC:53217-054-90	90 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090216	05/24/2010

LABELER - Aidarex Pharmaceuticals LLC(801503249)

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