Sunitinib Malate NDC 0378-6680

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6680Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6680Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-6680-28	00378668028	28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6680-28)Marketed from Jan 4, 2022

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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201275
Marketing start: Jan 4, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0378-6680_9e441770-fe62-43c0-b293-7ebc8f753ebcSPL ID 9e441770-fe62-43c0-b293-7ebc8f753ebcSPL set ID 4dbfcc02-dacc-4f0c-9f41-095783b68e27RxCUI 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

N400378668028 followed by a unit qualifier and the quantity

Package 00378-6680-28. 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 Aug 15, 2023. 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 stro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201275

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 201275
Product	Strength	Form · route	Labeler	Product NDC
Sunitinib Malate	Sunitinib malate 25 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6679
Sunitinib Malate	Sunitinib malate 37.5 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6681
Sunitinib Malate	Sunitinib malate 12.5 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6678