raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name raloxifene hydrochloride
Generic Name raloxifene hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

raloxifene hydrochloride 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-053
Product ID 71610-053_29e0719a-c1c4-429b-8544-f1efe06c33fd
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 71610053
Hyphenated Format 71610-053

Supplemental Identifiers

RxCUI
1490065
UNII
4F86W47BR6

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
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-053-60)
source: ndc

Packages (1)

71610-053-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-053-60)

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": "29e0719a-c1c4-429b-8544-f1efe06c33fd", "openfda": {"unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["6fd63a06-5bc5-4c50-9b85-b09c89100b80"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-053-60)", "package_ndc": "71610-053-60", "marketing_start_date": "20180426"}], "brand_name": "Raloxifene hydrochloride", "product_id": "71610-053_29e0719a-c1c4-429b-8544-f1efe06c33fd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "71610-053", "generic_name": "Raloxifene hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}