NDC product

Sorafenib Tosylate

NDC 0378-1201 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-1201
Proprietary name Sorafenib Tosylate
Nonproprietary name Sorafenib
Substances SORAFENIB TOSYLATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA207012
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
Marketing start Jun 1, 2022
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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