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
f8bd17b4-5289-45bb-8095-de89dc8d39ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, Inc.
DUNS: 047251004
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 Code0832-0595
Application NumberANDA209208
Product Classification
M
Marketing Category
C73584
G
Generic Name
Exemestane
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (11)
ExemestaneActive
Quantity: 25 mg in 1 1
Code: NY22HMQ4BX
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
crospovidone (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT