raloxifene hydrochloride

Generic: raloxifene

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name raloxifene hydrochloride
Generic Name raloxifene
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

raloxifene hydrochloride 60 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-825
Product ID 69097-825_ebab2c47-9350-447a-9372-7ade623d5bb1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090842
Listing Expiration 2026-12-31
Marketing Start 2016-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097825
Hyphenated Format 69097-825

Supplemental Identifiers

RxCUI
1490065
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 (source: ndc)
Application Number ANDA090842 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-825-02)
  • 100 TABLET in 1 BOTTLE (69097-825-07)
  • 1000 TABLET in 1 BOTTLE (69097-825-15)
source: ndc

Packages (3)

69097-825-02 30 TABLET in 1 BOTTLE (69097-825-02) 69097-825-07 100 TABLET in 1 BOTTLE (69097-825-07) 69097-825-15 1000 TABLET in 1 BOTTLE (69097-825-15)

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": "ebab2c47-9350-447a-9372-7ade623d5bb1", "openfda": {"unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["8fef5bfd-a786-4442-b09b-f3b81812cdac"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-825-02)", "package_ndc": "69097-825-02", "marketing_start_date": "20160629"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-825-07)", "package_ndc": "69097-825-07", "marketing_start_date": "20160629"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69097-825-15)", "package_ndc": "69097-825-15", "marketing_start_date": "20160629"}], "brand_name": "Raloxifene Hydrochloride", "product_id": "69097-825_ebab2c47-9350-447a-9372-7ade623d5bb1", "dosage_form": "TABLET", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "69097-825", "generic_name": "Raloxifene", "labeler_name": "Cipla USA 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": "20160629", "listing_expiration_date": "20261231"}