Prescription drug · ANDA
Sunitinib Malate NDC 43598-047
Sunitinib malate 37.5 mg/1 · Capsule · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-047-28 | 43598004728 | 4 BLISTER PACK in 1 CARTON (43598-047-28) / 7 CAPSULE in 1 BLISTER PACK (43598-047-70)Marketed from Nov 30, 2022 | |
| 43598-047-63 | 43598004763 | 28 CAPSULE in 1 BOTTLE (43598-047-63)Marketed from Nov 30, 2022 |
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
- Dr.Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215843
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-047_664e6a61-82ff-5756-1fc1-9266090d901eSPL ID 664e6a61-82ff-5756-1fc1-9266090d901eSPL set ID 96ce8850-b5ae-382b-8433-04949533af44RxCUI 616279, 616285, 616289, 1541890UNII LVX8N1UT73UPC 0343598048635, 0343598046631, 0343598045634, 0343598047638
- 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
N443598004728followed by a unit qualifier and the quantityPackage 43598-0047-28. 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 215843
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 50 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-048 |
| Sunitinib Malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-045 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-046 |