Evista
These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA.EVISTA (raloxifene hydrochloride) Tablet for Oral UseInitial U.S. Approval: 1997
Approved
Approval ID
fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Raloxifene hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-4184
Application NumberNDA020815
Product Classification
M
Marketing Category
C73594
G
Generic Name
Raloxifene hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2023
FDA Product Classification
INGREDIENTS (12)
Raloxifene hydrochlorideActive
Quantity: 60 mg in 1 1
Code: 4F86W47BR6
Classification: ACTIB
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT