Nilotinib NDC 31722-779

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-779Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0779Add 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
31722-779-33	31722077933	4 BLISTER PACK in 1 CARTON (31722-779-33) / 28 CAPSULE in 1 BLISTER PACKMarketed from Nov 19, 2025

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): Nilotinib
Generic name (nonproprietary): nilotinib
Active ingredients: Nilotinib — 150 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209651
Marketing start: Nov 19, 2025
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 31722-779_44065ee4-1b6c-f3ef-e063-6394a90a797aSPL ID 44065ee4-1b6c-f3ef-e063-6394a90a797aSPL set ID 86dc5507-ae0a-43d2-8d5e-5b0568ce9c5eRxCUI 746606, 997653UNII 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

N431722077933 followed by a unit qualifier and the quantity

Package 31722-0779-33. 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 Nov 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Nilotinib 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 Nilotinib capsules are indicated for the treatment of adult and p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209651

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

FDA NDC Directory listings under ANDA 209651
Product	Strength	Form · route	Labeler	Product NDC
Nilotinib	Nilotinib 200 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-780