Raloxifene hydrochloride
These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE tablets, USP safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE tablets, USP. RALOXIFENE HYDROCHLORIDE tablets, USP for Oral Use Initial U.S. Approval: 1997
Approved
Approval ID
ad3ef791-ac90-4f66-8da6-95b31e4c3eb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-1460
Application NumberANDA206384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Raloxifene hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2020
FDA Product Classification
INGREDIENTS (10)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
RALOXIFENE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 4F86W47BR6
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT