Prescription drug · ANDA
Sunitinib malate NDC 63304-091
Sunitinib malate 12.5 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-091-27 | 6330400912763304009127 | 28 CAPSULE in 1 BOTTLE (63304-091-27)Marketed from Dec 25, 2019 | |
| 63304-091-86 | 6330400918663304009186 | 4 BLISTER PACK in 1 BOX (63304-091-86) / 7 CAPSULE in 1 BLISTER PACK (63304-091-11)Marketed from Dec 25, 2019 |
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
- Sun Pharmaceutical Industries Inc.NDC labeler code 63304
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213914
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63304-091_2971c7ca-50dc-e36c-e063-6294a90a4b7dSPL ID 2971c7ca-50dc-e36c-e063-6294a90a4b7dSPL set ID 06e0ad28-6637-4f54-879c-2c194aece5fdRxCUI 616279, 616285, 616289, 1541890UNII LVX8N1UT73UPC 0363304092271
- 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
N463304009127followed by a unit qualifier and the quantityPackage 63304-0091-27. 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 (GIST)…
Excerpt only. Read the full label for complete information.
About NDC 63304-091
- What is NDC 63304-091?
- 63304-091 is the product NDC for Sunitinib malate, Sunitinib malate 12.5 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sunitinib malate.
- What is the active ingredient?
- Sunitinib malate.
- Who is the labeler?
- Sun Pharmaceutical Industries Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sunitinib malate?
- 31 other product NDCs are listed under this name. See all Sunitinib malate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sunitinib malate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sunitinib Malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-116 | 72205-0116-28 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-117 | 72205-0117-28 |
| Sunitinib Malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-118 | 72205-0118-28 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-119 | 72205-0119-28 |
| Sunitinib Malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-014 | 82293-0014-10 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-015 | 82293-0015-10 |
| Sunitinib Malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-016 | 82293-0016-10 |
| Sunitinib Malate | Sunitinib malate 50 mg/1 | CapsuleOral | Novugen Pharma (USA) LLC. | 82293-017 | 82293-0017-10 |
| Sunitinib Malate | Sunitinib malate 12.5 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-464 | 59651-0464-2859651-0464-29 |
| Sunitinib Malate | Sunitinib malate 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-465 | 59651-0465-2859651-0465-29 |
Other NDCs under ANDA 213914
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 | Sun Pharmaceutical Industries Inc. | 63304-092 |
| Sunitinib malate | Sunitinib malate 37.5 mg/1 | CapsuleOral | Sun Pharmaceutical Industries Inc. | 63304-093 |
| Sunitinib malate | Sunitinib malate 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries Inc. | 63304-094 |