raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name raloxifene hydrochloride
Generic Name raloxifene hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

raloxifene hydrochloride 60 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-057
Product ID 65162-057_767be874-7e9d-4d7d-9dc0-ba3fc6fe77d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208206
Listing Expiration 2026-12-31
Marketing Start 2016-01-20

Pharmacologic Class

Classes
estrogen agonist/antagonist [epc] selective estrogen receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162057
Hyphenated Format 65162-057

Supplemental Identifiers

RxCUI
1490065
UNII
4F86W47BR6

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name raloxifene hydrochloride (source: ndc)
Generic Name raloxifene hydrochloride (source: ndc)
Application Number ANDA208206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65162-057-09)
  • 100 TABLET, FILM COATED in 1 BOTTLE (65162-057-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11)
  • 2000 TABLET, FILM COATED in 1 BOTTLE (65162-057-33)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65162-057-50)
source: ndc

Packages (6)

65162-057-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03) 65162-057-09 90 TABLET, FILM COATED in 1 BOTTLE (65162-057-09) 65162-057-10 100 TABLET, FILM COATED in 1 BOTTLE (65162-057-10) 65162-057-11 1000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11) 65162-057-33 2000 TABLET, FILM COATED in 1 BOTTLE (65162-057-33) 65162-057-50 500 TABLET, FILM COATED in 1 BOTTLE (65162-057-50)

Ingredients (1)

raloxifene hydrochloride (60 mg/1)

Linked Drug Pages (1)

Raloxifene Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "767be874-7e9d-4d7d-9dc0-ba3fc6fe77d8", "openfda": {"unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["3798c70b-a4b0-4811-9788-e4c9cff47ebe"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03)", "package_ndc": "65162-057-03", "marketing_start_date": "20160120"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65162-057-09)", "package_ndc": "65162-057-09", "marketing_start_date": "20160120"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65162-057-10)", "package_ndc": "65162-057-10", "marketing_start_date": "20160120"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11)", "package_ndc": "65162-057-11", "marketing_start_date": "20160120"}, {"sample": false, "description": "2000 TABLET, FILM COATED in 1 BOTTLE (65162-057-33)", "package_ndc": "65162-057-33", "marketing_start_date": "20160120"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65162-057-50)", "package_ndc": "65162-057-50", "marketing_start_date": "20160120"}], "brand_name": "Raloxifene Hydrochloride", "product_id": "65162-057_767be874-7e9d-4d7d-9dc0-ba3fc6fe77d8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "65162-057", "generic_name": "Raloxifene Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Raloxifene Hydrochloride", "active_ingredients": [{"name": "RALOXIFENE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208206", "marketing_category": "ANDA", "marketing_start_date": "20160120", "listing_expiration_date": "20261231"}