EXEMESTANE- exemestane tablet 
Cadila Healthcare Limited

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EXEMESTANE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1374-3 in bottle of 30 tablets

Exemestane Tablets, 25 mg

Rx only

30 tablets

Exemestane Tablets, 25 mg
EXEMESTANE 
exemestane tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1374
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX) EXEMESTANE25 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 383
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1374-330 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20260210/08/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1374) , MANUFACTURE(70771-1374)

Revised: 8/2020
Document Id: eb18191a-ed37-40dd-8da8-0a2011605726
Set id: fab5468a-d5b7-45e3-b8b2-ed902fddd3a6
Version: 4
Effective Time: 20200826
 
Cadila Healthcare Limited