Cavhanza (nilotinib) NDC 70709-191

NDC codes

FDA NDC Directory

Product NDC (as listed)70709-191Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70709-0191Add 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
70709-191-12	70709019112	112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-191-12)Marketed from Jun 30, 2026

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): Cavhanza
Generic name (nonproprietary): nilotinib
Active ingredients: Nilotinib — 60 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Cycle Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217379
Marketing start: Jun 30, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
Identifiers: Product ID 70709-191_8991c94b-a4c1-46f8-aafe-a106aba4f8cfSPL ID 8991c94b-a4c1-46f8-aafe-a106aba4f8cfSPL set ID 98b197ea-bca4-427e-8737-97f70a3262bcRxCUI 2747509, 2747516, 2747518, 2747520UNII F41401512XUPC 0370709191126
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

N470709019112 followed by a unit qualifier and the quantity

Package 70709-0191-12. 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 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

CAVHANZA is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP CAVHANZA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. 1.2 Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP CAVHANZA is indicated for the treatment of adult patients with chronic …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 217379

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

FDA NDC Directory listings under NDA 217379
Product	Strength	Form · route	Labeler	Product NDC
Cavhanzanilotinib	Nilotinib 80 mg/1	Tablet, Orally disintegratingOral	Cycle Pharmaceuticals Ltd	70709-192