sorafenib tosylate

Generic: sorafenib

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

Drug Facts

Product Profile

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

sorafenib tosylate 200 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1201
Product ID 0378-1201_49d8d8dd-8190-40fc-a42a-0e3e188f5cb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207012
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781201
Hyphenated Format 0378-1201

Supplemental Identifiers

RxCUI
597747
UPC
0303781201780
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 tosylate (source: ndc)
Generic Name sorafenib (source: ndc)
Application Number ANDA207012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)
source: ndc

Packages (1)

0378-1201-78 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)

Ingredients (1)

sorafenib tosylate (200 mg/1)

Linked Drug Pages (1)

Sorafenib Tosylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49d8d8dd-8190-40fc-a42a-0e3e188f5cb6", "openfda": {"upc": ["0303781201780"], "unii": ["5T62Q3B36J"], "rxcui": ["597747"], "spl_set_id": ["b7919013-1511-44f0-a759-3fa78a9fa178"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)", "package_ndc": "0378-1201-78", "marketing_start_date": "20220601"}], "brand_name": "Sorafenib Tosylate", "product_id": "0378-1201_49d8d8dd-8190-40fc-a42a-0e3e188f5cb6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0378-1201", "generic_name": "Sorafenib", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sorafenib Tosylate", "active_ingredients": [{"name": "SORAFENIB TOSYLATE", "strength": "200 mg/1"}], "application_number": "ANDA207012", "marketing_category": "ANDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}