Exemestane
These highlights do not include all the information needed to use EXEMESTANE TABLETS safely and effectively. See full prescribing information for EXEMESTANE TABLETS. EXEMESTANE tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
11d5a86e-7861-43f1-ae04-84daa0de7888
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Exemestane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-240
Application NumberANDA206421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Exemestane
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2022
FDA Product Classification
INGREDIENTS (12)
EXEMESTANEActive
Quantity: 25 mg in 1 1
Code: NY22HMQ4BX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT