Prescription drug · ANDA
Sorafenib NDC 0480-5425
Sorafenib tosylate 200 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-5425-89 | 00480542589 | 120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89)Marketed from Jan 3, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Sorafenib
- Generic name (nonproprietary)
- sorafenib
- Active ingredients
- Sorafenib tosylate — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209567
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0480-5425_5f4a23bc-d026-46f0-b028-d92130032dc0SPL ID 5f4a23bc-d026-46f0-b028-d92130032dc0SPL set ID dae598f7-823f-405c-ae31-f924594187b9RxCUI 597747UNII 5T62Q3B36JUPC 0304805425892
- 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
N400480542589followed by a unit qualifier and the quantityPackage 00480-5425-89. 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 .
Indications (excerpt from the label)
Sorafenib 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 Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressiv…
Excerpt only. Read the full label for complete information.