raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

raloxifene hydrochloride 60 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-213
Product ID 16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87
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 16714213
Hyphenated Format 16714-213

Supplemental Identifiers

RxCUI
1490065
UPC
0316714213019
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03)
source: ndc

Packages (3)

16714-213-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01) 16714-213-02 100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02) 16714-213-03 1000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03)

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": "145e48c3-0ef5-41f7-adc2-ab0a7ca89d87", "openfda": {"upc": ["0316714213019"], "unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01)", "package_ndc": "16714-213-01", "marketing_start_date": "20150828"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02)", "package_ndc": "16714-213-02", "marketing_start_date": "20150828"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03)", "package_ndc": "16714-213-03", "marketing_start_date": "20150828"}], "brand_name": "Raloxifene Hydrochloride", "product_id": "16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "16714-213", "generic_name": "Raloxifene Hydrochloride", "labeler_name": "NorthStar Rx LLC", "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"}