Raloxifene Hydrochloride
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
a5102b05-a7b3-4b48-9ed8-a398cce78ea9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2021
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-504
Application NumberANDA078193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Raloxifene Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2021
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
RALOXIFENE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 4F86W47BR6
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT