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
2b94ecf5-d870-4132-b455-d5ee5c9dce56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2020
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
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 Code76282-256
Application NumberANDA090842
Product Classification
M
Marketing Category
C73584
G
Generic Name
Raloxifene Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2019
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
RALOXIFENE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 4F86W47BR6
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT