nexavar

Generic: sorafenib

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

sorafenib 200 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-489
Product ID 50419-489_e597a26e-e04a-4f91-8c7c-a83243286396
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021923
Listing Expiration 2026-12-31
Marketing Start 2023-10-02

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419489
Hyphenated Format 50419-489

Supplemental Identifiers

RxCUI
597747 615979
UNII
9ZOQ3TZI87
NUI
N0000175605 N0000175076

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 nexavar (source: ndc)
Generic Name sorafenib (source: ndc)
Application Number NDA021923 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)
source: ndc

Packages (1)

50419-489-01 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)

Ingredients (1)

sorafenib (200 mg/1)

Linked Drug Pages (1)

Nexavar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e597a26e-e04a-4f91-8c7c-a83243286396", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["9ZOQ3TZI87"], "rxcui": ["597747", "615979"], "spl_set_id": ["b50667e4-5ebc-4968-a646-d605058dbef0"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)", "package_ndc": "50419-489-01", "marketing_start_date": "20231002"}], "brand_name": "Nexavar", "product_id": "50419-489_e597a26e-e04a-4f91-8c7c-a83243286396", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "50419-489", "generic_name": "sorafenib", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexavar", "active_ingredients": [{"name": "SORAFENIB", "strength": "200 mg/1"}], "application_number": "NDA021923", "marketing_category": "NDA", "marketing_start_date": "20231002", "listing_expiration_date": "20261231"}