Prescription drug · ANDA
Sunitinib Malate NDC 59651-464
Sunitinib malate 12.5 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-464-28 | 59651046428 | 28 CAPSULE in 1 BOTTLE (59651-464-28)Marketed from Mar 14, 2024 | |
| 59651-464-29 | 59651046429 | 4 BLISTER PACK in 1 CARTON (59651-464-29) / 7 CAPSULE in 1 BLISTER PACKMarketed from Mar 14, 2024 |
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)
- Sunitinib Malate
- Generic name (nonproprietary)
- sunitinib malate
- Active ingredients
- Sunitinib malate — 12.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218615
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-464_a3d2b07e-f9d2-4f17-9a80-025d77ff8f7eSPL ID a3d2b07e-f9d2-4f17-9a80-025d77ff8f7eSPL set ID 810dfcb2-d35b-4971-887c-2e78e82e9e07RxCUI 616279, 616285, 616289, 1541890UNII LVX8N1UT73UPC 0359651466292, 0359651465295, 0359651467299
- 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
N459651046428followed by a unit qualifier and the quantityPackage 59651-0464-28. 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)
Sunitinib malate 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 Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218615
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 |
|---|---|---|---|---|
| Sunitinib Malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-466 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-465 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-467 |