raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

raloxifene hydrochloride 60 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-306
Product ID 50228-306_f1da5bd3-72c2-15ff-e053-2995a90a89db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206384
Listing Expiration 2026-12-31
Marketing Start 2016-10-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228306
Hyphenated Format 50228-306

Supplemental Identifiers

RxCUI
1490065
UPC
0350228306201 0350228306300
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 ANDA206384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 2000 TABLET, FILM COATED in 1 BOTTLE (50228-306-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-306-30)
source: ndc

Packages (2)

50228-306-20 2000 TABLET, FILM COATED in 1 BOTTLE (50228-306-20) 50228-306-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-306-30)

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": "f1da5bd3-72c2-15ff-e053-2995a90a89db", "openfda": {"upc": ["0350228306201", "0350228306300"], "unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["8152e68b-61a8-4897-8e03-900135b1dbd5"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2000 TABLET, FILM COATED in 1 BOTTLE (50228-306-20)", "package_ndc": "50228-306-20", "marketing_start_date": "20161012"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-306-30)", "package_ndc": "50228-306-30", "marketing_start_date": "20161012"}], "brand_name": "Raloxifene hydrochloride", "product_id": "50228-306_f1da5bd3-72c2-15ff-e053-2995a90a89db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "50228-306", "generic_name": "Raloxifene hydrochloride", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Raloxifene hydrochloride", "active_ingredients": [{"name": "RALOXIFENE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA206384", "marketing_category": "ANDA", "marketing_start_date": "20161012", "listing_expiration_date": "20261231"}