raloxifene hydrochloride

Generic: raloxifene hydrochloride

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name raloxifene hydrochloride
Generic Name raloxifene hydrochloride
Labeler cadila pharmaceuticals limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

raloxifene hydrochloride 60 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-082
Product ID 71209-082_14d4c334-b49d-4479-a91e-20b7276b4eca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211324
Listing Expiration 2026-12-31
Marketing Start 2017-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209082
Hyphenated Format 71209-082

Supplemental Identifiers

RxCUI
1490065
UPC
0371209082112
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 ANDA211324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (71209-082-01)
  • 100 TABLET, COATED in 1 BOTTLE (71209-082-05)
  • 1000 TABLET, COATED in 1 BOTTLE (71209-082-11)
  • 2000 TABLET, COATED in 1 BOTTLE (71209-082-13)
source: ndc

Packages (4)

71209-082-01 30 TABLET, COATED in 1 BOTTLE (71209-082-01) 71209-082-05 100 TABLET, COATED in 1 BOTTLE (71209-082-05) 71209-082-11 1000 TABLET, COATED in 1 BOTTLE (71209-082-11) 71209-082-13 2000 TABLET, COATED in 1 BOTTLE (71209-082-13)

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": "14d4c334-b49d-4479-a91e-20b7276b4eca", "openfda": {"upc": ["0371209082112"], "unii": ["4F86W47BR6"], "rxcui": ["1490065"], "spl_set_id": ["a46bcc4f-f63d-4200-836d-a653a3c616db"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (71209-082-01)", "package_ndc": "71209-082-01", "marketing_start_date": "20171230"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (71209-082-05)", "package_ndc": "71209-082-05", "marketing_start_date": "20171230"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (71209-082-11)", "package_ndc": "71209-082-11", "marketing_start_date": "20211213"}, {"sample": false, "description": "2000 TABLET, COATED in 1 BOTTLE (71209-082-13)", "package_ndc": "71209-082-13", "marketing_start_date": "20171230"}], "brand_name": "Raloxifene hydrochloride", "product_id": "71209-082_14d4c334-b49d-4479-a91e-20b7276b4eca", "dosage_form": "TABLET, COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "71209-082", "generic_name": "Raloxifene hydrochloride", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Raloxifene hydrochloride", "active_ingredients": [{"name": "RALOXIFENE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211324", "marketing_category": "ANDA", "marketing_start_date": "20171230", "listing_expiration_date": "20261231"}