raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

raloxifene hydrochloride 60 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-694
Product ID 50268-694_48255cf3-7607-03f0-e063-6394a90ae486
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208206
Listing Expiration 2027-12-31
Marketing Start 2018-06-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268694
Hyphenated Format 50268-694

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 ANDA208206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11)
source: ndc

Packages (1)

50268-694-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11)

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": "48255cf3-7607-03f0-e063-6394a90ae486", "openfda": {"unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["6f7eb934-aa60-51e1-e053-2a91aa0a3914"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11)", "package_ndc": "50268-694-15", "marketing_start_date": "20180627"}], "brand_name": "Raloxifene Hydrochloride", "product_id": "50268-694_48255cf3-7607-03f0-e063-6394a90ae486", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "50268-694", "generic_name": "Raloxifene Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Raloxifene Hydrochloride", "active_ingredients": [{"name": "RALOXIFENE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208206", "marketing_category": "ANDA", "marketing_start_date": "20180627", "listing_expiration_date": "20271231"}