NDC 50419-488

Nexavar

Sorafenib

Nexavar is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Sorafenib.

• Product ID: 50419-488_20ab7dba-4d59-4221-ad33-2dc86cd4f4e5
• NDC: 50419-488
• Product Type: Human Prescription Drug
• Proprietary Name: Nexavar
• Generic Name: Sorafenib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-12-20
• Marketing Category: NDA / NDA
• Application Number: NDA021923
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: SORAFENIB
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50419-488-58

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-488-58)

• Marketing Start Date: 2005-12-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-488-58 [50419048858]

Nexavar TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021923
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-12-20

Drug Details

Active Ingredients

Ingredient	Strength
SORAFENIB	200 mg/1

OpenFDA Data

• SPL SET ID: b50667e4-5ebc-4968-a646-d605058dbef0
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 9ZOQ3TZI87
• RxNorm Concept Unique ID - RxCUI:
  • 597747
  • 615979

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "Nexavar" or generic name "Sorafenib"

NDC	Brand Name	Generic Name
50419-488	Nexavar	sorafenib
0480-5425	Sorafenib	Sorafenib
24979-715	Sorafenib	Sorafenib
43598-458	sorafenib	sorafenib
51990-201	Sorafenib	Sorafenib
0378-1201	Sorafenib Tosylate	Sorafenib