vanrafia

Generic: atrasentan

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vanrafia
Generic Name atrasentan
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atrasentan hydrochloride .75 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1420
Product ID 0078-1420_af74a97e-160b-4335-9bc5-97a29e721d1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219208
Listing Expiration 2026-12-31
Marketing Start 2025-04-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781420
Hyphenated Format 0078-1420

Supplemental Identifiers

RxCUI
2710454 2710460
UNII
E4G31X93ZA

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 vanrafia (source: ndc)
Generic Name atrasentan (source: ndc)
Application Number NDA219208 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15)
source: ndc

Packages (1)

0078-1420-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15)

Ingredients (1)

atrasentan hydrochloride (.75 mg/1)

Linked Drug Pages (1)

VANRAFIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "af74a97e-160b-4335-9bc5-97a29e721d1b", "openfda": {"unii": ["E4G31X93ZA"], "rxcui": ["2710454", "2710460"], "spl_set_id": ["9a7e7f85-bfd0-44a0-beda-3bcfa8215c64"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15)", "package_ndc": "0078-1420-15", "marketing_start_date": "20250402"}], "brand_name": "VANRAFIA", "product_id": "0078-1420_af74a97e-160b-4335-9bc5-97a29e721d1b", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0078-1420", "generic_name": "atrasentan", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VANRAFIA", "active_ingredients": [{"name": "ATRASENTAN HYDROCHLORIDE", "strength": ".75 mg/1"}], "application_number": "NDA219208", "marketing_category": "NDA", "marketing_start_date": "20250402", "listing_expiration_date": "20261231"}