Prescription drug · NDA
Sutent (Sunitinib malate) NDC 0069-0980
Sunitinib malate 50 mg/1 · Capsule · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0980-38 | 0006909803800069098038 | 28 CAPSULE in 1 BOTTLE (0069-0980-38)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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021938
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0069-0980_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
N400069098038followed by a unit qualifier and the quantityPackage 00069-0980-38. 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 . 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.
About NDC 0069-0980
- What is NDC 0069-0980?
- 0069-0980 is the product NDC for Sutent (sunitinib malate), Sunitinib malate 50 mg/1 capsule, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sutent (Sunitinib malate).
- What is the active ingredient?
- Sunitinib malate.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sutent?
- 3 other product NDCs are listed under this name. See all Sutent NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sutent products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sutentsunitinib malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0830 | 00069-0830-38 |
| Sutentsunitinib malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0550 | 00069-0550-38 |
| Sutentsunitinib malate | Sunitinib malate 25 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0770 | 00069-0770-38 |
Other NDCs under NDA 021938
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sutentsunitinib malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0550 |
| 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 |