NDC Code(s) : 54569-5752-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KaletraLopinavir and Ritonavir TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5752(NDC:0074-6799)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPINAVIR(UNII: 2494G1JF75)
(LOPINAVIR - UNII:2494G1JF75) 		LOPINAVIR200 mg
RITONAVIR(UNII: O3J8G9O825)
(RITONAVIR - UNII:O3J8G9O825) 		RITONAVIR50 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31(UNII: D9C330MD8B)
SORBITAN MONOLAURATE(UNII: 6W9PS8B71J)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code a;KA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5752-0120 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021906 06/18/2010

PRINCIPAL DISPLAY PANEL

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