raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name raloxifene hydrochloride
Generic Name raloxifene hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

raloxifene hydrochloride 60 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-709
Product ID 65862-709_161df518-c043-4476-968b-d0268ae03fd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204310
Listing Expiration 2026-12-31
Marketing Start 2015-08-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862709
Hyphenated Format 65862-709

Supplemental Identifiers

RxCUI
1490065
UPC
0365862709301
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 ANDA204310 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01)
  • 3 BLISTER PACK in 1 CARTON (65862-709-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10)
  • 2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99)
source: ndc

Packages (5)

65862-709-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01) 65862-709-03 3 BLISTER PACK in 1 CARTON (65862-709-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10) 65862-709-22 2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22) 65862-709-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30) 65862-709-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99)

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": "161df518-c043-4476-968b-d0268ae03fd5", "openfda": {"upc": ["0365862709301"], "unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01)", "package_ndc": "65862-709-01", "marketing_start_date": "20150828"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-709-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10)", "package_ndc": "65862-709-03", "marketing_start_date": "20150828"}, {"sample": false, "description": "2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22)", "package_ndc": "65862-709-22", "marketing_start_date": "20150828"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30)", "package_ndc": "65862-709-30", "marketing_start_date": "20150828"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99)", "package_ndc": "65862-709-99", "marketing_start_date": "20150828"}], "brand_name": "Raloxifene Hydrochloride", "product_id": "65862-709_161df518-c043-4476-968b-d0268ae03fd5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "65862-709", "generic_name": "Raloxifene Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Raloxifene Hydrochloride", "active_ingredients": [{"name": "RALOXIFENE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA204310", "marketing_category": "ANDA", "marketing_start_date": "20150828", "listing_expiration_date": "20261231"}