Danziten (nilotinib) NDC 24338-154

NDC codes

FDA NDC Directory

Product NDC (as listed)24338-154Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24338-0154Add 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
24338-154-01	24338015401	4 CARTON in 1 CARTON (24338-154-01) / 2 BLISTER PACK in 1 CARTON (24338-154-02) / 14 TABLET in 1 BLISTER PACK (24338-154-03)Marketed from Nov 30, 2024

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): Danziten
Generic name (nonproprietary): nilotinib
Active ingredients: Nilotinib — 71 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Azurity Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219293
Marketing start: Nov 30, 2024
Listing expires: Dec 31, 2026
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 24338-154_62029a35-74af-47bc-9b7b-93dcaddfd278SPL ID 62029a35-74af-47bc-9b7b-93dcaddfd278SPL set ID d288d165-3505-49bb-9b2e-124490d65f49RxCUI 2698564, 2698570, 2698572, 2698574UNII F41401512X
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

N424338015401 followed by a unit qualifier and the quantity

Package 24338-0154-01. 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 Jul 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

DANZITEN 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 DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 219293

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

FDA NDC Directory listings under NDA 219293
Product	Strength	Form · route	Labeler	Product NDC
Danzitennilotinib	Nilotinib 95 mg/1	TabletOral	Azurity Pharmaceuticals, Inc.	24338-155