Raloxifene hydrochloride
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets for oral use Initial U.S. Approval: 1997
Approved
Approval ID
22a951ee-2ffc-4c60-b681-0f80285153e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6177
Application NumberANDA211324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Raloxifene hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RALOXIFENE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 4F86W47BR6
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT