Exemestane: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 71921-190 -33

Exemestane

Tablets, USP

25 mg

FPP logo Rx only

30 tablets

image description
(click image for full-size original)
EXEMESTANE exemestane tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71921-190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EXEMESTANE (EXEMESTANE) EXEMESTANE 25 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
POLYSORBATE 80
HYPROMELLOSE 2910 (5 MPA.S)
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (White or almost white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71921-190-33 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71921-190-09 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213547 01/15/2021
Labeler — Florida Pharmaceutical Products, LLC (084014259)
Establishment
Name Address ID/FEI Operations
Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park) 544532200 manufacture (71921-190), analysis (71921-190), label (71921-190)

Revised: 01/2022 Florida Pharmaceutical Products, LLC

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