Prescription drug · ANDA
Sunitinib Malate NDC 72205-116
Sunitinib malate 12.5 mg/1 · Capsule · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-116-28 | 72205011628 | 28 CAPSULE in 1 BOTTLE (72205-116-28)Marketed from Jun 1, 2025 |
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
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214824
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 72205-116_15dd0555-b33f-4f56-94d3-0f4ce888df01SPL ID 15dd0555-b33f-4f56-94d3-0f4ce888df01SPL set ID 15dd0555-b33f-4f56-94d3-0f4ce888df01RxCUI 616279, 616285, 616289, 1541890UNII LVX8N1UT73UPC 0372205118287, 0372205116283, 0372205119284, 0372205117280
- 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
N472205011628followed by a unit qualifier and the quantityPackage 72205-0116-28. 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 capsule 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214824
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 25 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-117 |
| Sunitinib Malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-118 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-119 |