sorafenib

Generic: sorafenib

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sorafenib
Generic Name sorafenib
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sorafenib tosylate 200 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-5425
Product ID 0480-5425_213b5f06-be1f-4bc1-b09d-86c12f83d3b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209567
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04805425
Hyphenated Format 0480-5425

Supplemental Identifiers

RxCUI
597747
UPC
0304805425892
UNII
5T62Q3B36J

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 sorafenib (source: ndc)
Generic Name sorafenib (source: ndc)
Application Number ANDA209567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89)
source: ndc

Packages (1)

0480-5425-89 120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89)

Ingredients (1)

sorafenib tosylate (200 mg/1)

Linked Drug Pages (1)

Sorafenib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "213b5f06-be1f-4bc1-b09d-86c12f83d3b9", "openfda": {"upc": ["0304805425892"], "unii": ["5T62Q3B36J"], "rxcui": ["597747"], "spl_set_id": ["dae598f7-823f-405c-ae31-f924594187b9"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89)", "package_ndc": "0480-5425-89", "marketing_start_date": "20230103"}], "brand_name": "Sorafenib", "product_id": "0480-5425_213b5f06-be1f-4bc1-b09d-86c12f83d3b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0480-5425", "generic_name": "Sorafenib", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sorafenib", "active_ingredients": [{"name": "SORAFENIB TOSYLATE", "strength": "200 mg/1"}], "application_number": "ANDA209567", "marketing_category": "ANDA", "marketing_start_date": "20230103", "listing_expiration_date": "20261231"}