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
9354d1a1-8e8c-4c6a-b7ad-d4fe14b10a8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2023
Manufacturers
FDA
Florida Pharmaceutical Products, LLC
DUNS: 084014259
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 Code71921-190
Application NumberANDA213547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Exemestane
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
EXEMESTANEActive
Quantity: 25 mg in 1 1
Code: NY22HMQ4BX
Classification: ACTIB