Prescription drug · ANDA
Sunitinib Malate NDC 0093-8199
Sunitinib malate 12.5 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-8199-28 | 00093819928 | 28 CAPSULE in 1 BOTTLE (0093-8199-28)Marketed from Dec 22, 2021 |
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)
- Sunitinib Malate
- Generic name (nonproprietary)
- sunitinib malate
- Active ingredients
- Sunitinib malate — 12.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213803
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-8199_71bcc3b2-9dea-4700-af34-a9a5d2b708a2SPL ID 71bcc3b2-9dea-4700-af34-a9a5d2b708a2SPL set ID a9479e5f-914f-46ca-95c1-327c66457e47RxCUI 616279, 616285, 616289, 1541890UNII LVX8N1UT73
- 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
N400093819928followed by a unit qualifier and the quantityPackage 00093-8199-28. 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 capsules are 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 213803
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 | Teva Pharmaceuticals USA, Inc. | 0093-8224 |
| Sunitinib Malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-8229 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-8231 |
| Sunitinib Malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | AvKARE | 42291-901 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | AvKARE | 42291-902 |
| Sunitinib Malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | AvKARE | 42291-903 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | AvKARE | 42291-904 |