COARTEM (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 0078-0568-45 Rx only

Coartem®
(artemether/lumefantrine)Tablets

20 mg/120 mg per tablet

24 Tablets

NOVARTIS

Coartem Tablets label
(click image for full-size original)
COARTEM artemether and lumefantrine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0568
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMETHER (ARTEMETHER) ARTEMETHER 20 mg
LUMEFANTRINE (LUMEFANTRINE) LUMEFANTRINE 120 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
WATER
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND (round and flat tablet with bevelled edges) Size 9mm
Flavor Imprint Code N;C;CG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0568-45 24 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022268 04/07/2009
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2022 Novartis Pharmaceuticals Corporation

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