Tasigna (nilotinib) NDC 0078-0526

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0526Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0526Add 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
0078-0526-51	00078052651	28 CAPSULE in 1 BLISTER PACK (0078-0526-51)Marketed from Oct 29, 2007
0078-0526-87	00078052687	4 BLISTER PACK in 1 CARTON (0078-0526-87) / 28 CAPSULE in 1 BLISTER PACKMarketed from Oct 29, 2007

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): Tasigna
Generic name (nonproprietary): nilotinib
Active ingredients: Nilotinib hydrochloride monohydrate — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022068
Marketing start: Oct 29, 2007
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 0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102SPL ID fe0fef5b-4f09-4f67-946f-67e84d10e102SPL set ID 6093952a-5248-45cb-ad17-33716a411146RxCUI 746606, 746609, 997653, 1002300, 2002717, 2002719UNII 5JHU0N1R6K
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

N400078052651 followed by a unit qualifier and the quantity

Package 00078-0526-51. 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 Dec 16, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3 ) 1.1 Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Tasigna is indicated for the treatment of adult and pediatric patients gr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022068

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

FDA NDC Directory listings under NDA 022068
Product	Strength	Form · route	Labeler	Product NDC
Tasignanilotinib	Nilotinib hydrochloride monohydrate 50 mg/1	CapsuleOral	Novartis Pharmaceuticals Corporation	0078-0951
Tasignanilotinib	Nilotinib hydrochloride monohydrate 150 mg/1	CapsuleOral	Novartis Pharmaceuticals Corporation	0078-0592