Prescription drug · NDA
Cavhanza (Nilotinib) NDC 70709-192
Nilotinib 80 mg/1 · Tablet, Orally disintegrating · Oral · Cycle Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70709-192-12 | 7070901921270709019212 | 112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-192-12)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 — 80 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Cycle Pharmaceuticals LtdNDC labeler code 70709
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217379
- Marketing start
- Listing expires
- 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 70709-192_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
N470709019212followed by a unit qualifier and the quantityPackage 70709-0192-12. 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 . 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.
About NDC 70709-192
- What is NDC 70709-192?
- 70709-192 is the product NDC for Cavhanza (nilotinib), Nilotinib 80 mg/1 tablet, orally disintegrating, listed with the FDA by Cycle Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cavhanza (Nilotinib).
- What is the active ingredient?
- Nilotinib.
- Who is the labeler?
- Cycle Pharmaceuticals Ltd, NDC labeler code 70709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cavhanza?
- 1 other product NDC are listed under this name. See all Cavhanza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cavhanza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cavhanzanilotinib | Nilotinib 60 mg/1 | Tablet, Orally disintegratingOral | Cycle Pharmaceuticals Ltd | 70709-191 | 70709-0191-12 |
Other NDCs under NDA 217379
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 |
|---|---|---|---|---|
| Cavhanzanilotinib | Nilotinib 60 mg/1 | Tablet, Orally disintegratingOral | Cycle Pharmaceuticals Ltd | 70709-191 |