Bone Effects: Consideration should be given to monitoring bone mineral density.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, 07936
© Novartis
T2014-01
January 2014
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Package Label – 2.5 mg
Rx Only NDC 0078-0249-15
FEMARA® (letrozole tablets)
2.5 mg per tablet
30 Tablets
INGREDIENTS AND APPEARANCE
FEMARA
letrozole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0249
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LETROZOLE (UNII: 7LKK855W8I) (LETROZOLE - UNII:7LKK855W8I) LETROZOLE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape ROUND (slightly biconvex with beveled edges) Size 7mm
Flavor Imprint Code FV;CG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0249-15 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020726 07/31/1997
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