Sutent (sunitinib malate) NDC 0069-0550

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-0550Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-0550Add 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
0069-0550-38	00069055038	28 CAPSULE in 1 BOTTLE (0069-0550-38)Marketed from Jan 26, 2006

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): Sutent
Generic name (nonproprietary): sunitinib malate
Active ingredients: Sunitinib malate — 12.5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021938
Marketing start: Jan 26, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0069-0550_530eef58-b5ab-49f1-8d73-a2dae0356f24SPL ID 530eef58-b5ab-49f1-8d73-a2dae0356f24SPL set ID 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9cRxCUI 616279, 616283, 616285, 616287, 616289, 616292, 1541890, 1541928UNII LVX8N1UT73UPC 0300690980386, 0300690550381, 0300690830384, 0300690770383
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

N400069055038 followed by a unit qualifier and the quantity

Package 00069-0550-38. 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 Feb 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. ( 1.4 ) 1.1 Gastrointestinal Stromal Tumor SUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progressi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021938

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

FDA NDC Directory listings under NDA 021938
Product	Strength	Form · route	Labeler	Product NDC
Sutentsunitinib malate	Sunitinib malate 50 mg/1	CapsuleOral	Pfizer Laboratories Div Pfizer Inc	0069-0980
Sutentsunitinib malate	Sunitinib malate 25 mg/1	CapsuleOral	Pfizer Laboratories Div Pfizer Inc	0069-0770
Sutentsunitinib malate	Sunitinib malate 37.5 mg/1	CapsuleOral	Pfizer Laboratories Div Pfizer Inc	0069-0830