raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name raloxifene hydrochloride
Generic Name raloxifene hydrochloride
Labeler exelan pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

raloxifene hydrochloride 60 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-256
Product ID 76282-256_7238f870-72f1-4e67-9c88-5125522971da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090842
Listing Expiration 2026-12-31
Marketing Start 2014-11-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282256
Hyphenated Format 76282-256

Supplemental Identifiers

RxCUI
1490065
UPC
0376282256306
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 ANDA090842 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76282-256-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76282-256-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76282-256-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76282-256-90)
source: ndc

Packages (5)

76282-256-01 100 TABLET, FILM COATED in 1 BOTTLE (76282-256-01) 76282-256-05 500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05) 76282-256-10 1000 TABLET, FILM COATED in 1 BOTTLE (76282-256-10) 76282-256-30 30 TABLET, FILM COATED in 1 BOTTLE (76282-256-30) 76282-256-90 90 TABLET, FILM COATED in 1 BOTTLE (76282-256-90)

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": "7238f870-72f1-4e67-9c88-5125522971da", "openfda": {"upc": ["0376282256306"], "unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["2b94ecf5-d870-4132-b455-d5ee5c9dce56"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76282-256-01)", "package_ndc": "76282-256-01", "marketing_start_date": "20141112"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05)", "package_ndc": "76282-256-05", "marketing_start_date": "20141112"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76282-256-10)", "package_ndc": "76282-256-10", "marketing_start_date": "20150415"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76282-256-30)", "package_ndc": "76282-256-30", "marketing_start_date": "20141112"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76282-256-90)", "package_ndc": "76282-256-90", "marketing_start_date": "20150415"}], "brand_name": "Raloxifene Hydrochloride", "product_id": "76282-256_7238f870-72f1-4e67-9c88-5125522971da", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "76282-256", "generic_name": "Raloxifene Hydrochloride", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Raloxifene Hydrochloride", "active_ingredients": [{"name": "RALOXIFENE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090842", "marketing_category": "ANDA", "marketing_start_date": "20141112", "listing_expiration_date": "20261231"}