Exemestane
These highlights do not include all the information needed to use EXEMESTANE TABLETS safely and effectively. See full prescribing information for EXEMESTANE TABLETS.
Approved
Approval ID
88fb6543-383b-4195-a2c1-2673ac194f4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2021
Manufacturers
FDA
Eirgen Pharma Ltd
DUNS: 989968644
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 Code44278-025
Application NumberANDA200898
Product Classification
M
Marketing Category
C73584
G
Generic Name
EXEMESTANE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2021
FDA Product Classification
INGREDIENTS (10)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
EXEMESTANEActive
Quantity: 25 mg in 1 1
Code: NY22HMQ4BX
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT