Prescription drug · ANDA
Sunitinib Malate NDC 82293-016
Sunitinib malate 37.5 mg/1 · Capsule · Oral · Novugen Pharma (USA) LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82293-016-10 | 82293001610 | 28 CAPSULE in 1 BOTTLE (82293-016-10)Marketed from May 1, 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 — 37.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Novugen Pharma (USA) LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218012
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 82293-016_21d0ff80-d937-abb3-e063-6394a90af4b7SPL ID 21d0ff80-d937-abb3-e063-6394a90af4b7SPL set ID 04d34bce-1296-d2b9-e063-6394a90a7018RxCUI 616279, 616285, 616289, 1541890UNII LVX8N1UT73UPC 0382293017102, 0382293015108
- 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
N482293001610followed by a unit qualifier and the quantityPackage 82293-0016-10. 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) af…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218012
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 12.5 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-014 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-015 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-017 |