NDC 52343-137

Raloxifene Hydrochloride

Raloxifene Hydrochloride

Raloxifene Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Acetris Health, Llc. The primary component is Raloxifene Hydrochloride.

Product ID52343-137_d0f0c7e4-9cd5-4939-a619-ec103e800e0f
NDC52343-137
Product TypeHuman Prescription Drug
Proprietary NameRaloxifene Hydrochloride
Generic NameRaloxifene Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-08-28
Marketing End Date2020-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA204310
Labeler NameACETRIS HEALTH, LLC
Substance NameRALOXIFENE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesEstrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC Exclude FlagN

Packaging

NDC 52343-137-01

100 TABLET, FILM COATED in 1 BOTTLE (52343-137-01)
Marketing Start Date2015-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52343-137-01 [52343013701]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204310
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-28
Marketing End Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
RALOXIFENE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:f1eca4f3-47d4-4cfa-9aed-27b535281e14
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1490065
  • UPC Code
  • 0352343137012
  • Pharmacological Class

    • Estrogen Agonist/Antagonist [EPC]
    • Selective Estrogen Receptor Modulators [MoA]