Nexavar (sorafenib) NDC 50419-489

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-489Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0489Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50419-489-01	50419048901	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)Marketed from Oct 2, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Nexavar
Generic name (nonproprietary): sorafenib
Active ingredients: Sorafenib — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021923
Marketing start: Oct 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 50419-489_e597a26e-e04a-4f91-8c7c-a83243286396SPL ID e597a26e-e04a-4f91-8c7c-a83243286396SPL set ID b50667e4-5ebc-4968-a646-d605058dbef0RxCUI 597747, 615979UNII 9ZOQ3TZI87
Pharmacologic class: Kinase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450419048901 followed by a unit qualifier and the quantity

Package 50419-0489-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 28, 2023.

Indications (excerpt from the label)

NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021923

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021923
Product	Strength	Form · route	Labeler	Product NDC
Nexavarsorafenib	Sorafenib 200 mg/1	Tablet, Film coatedOral	Bayer HealthCare Pharmaceuticals Inc.	50419-488