nilotinib NDC 73190-034

NDC codes

FDA NDC Directory

Product NDC (as listed)73190-034Labeler and product segments. Claims need a package NDC.

Product NDC at billing width73190-0034Add 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
73190-034-11	73190003411	28 CAPSULE in 1 BLISTER PACK (73190-034-11)Marketed from Mar 2, 2026
73190-034-12	73190003412	4 BLISTER PACK in 1 CARTON (73190-034-12) / 28 CAPSULE in 1 BLISTER PACKMarketed from Mar 2, 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): nilotinib
Generic name (nonproprietary): nilotinib
Active ingredients: Nilotinib — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218544
Marketing start: Mar 2, 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 73190-034_4c0bc87a-7a6c-af1e-e063-6394a90a5495SPL ID 4c0bc87a-7a6c-af1e-e063-6394a90a5495SPL set ID 4c0bc799-ce6a-822a-e063-6394a90ab748RxCUI 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

N473190003411 followed by a unit qualifier and the quantity

Package 73190-0034-11. 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 Mar 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Nilotinib capsules are 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 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 pediatric …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218544

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

FDA NDC Directory listings under ANDA 218544
Product	Strength	Form · route	Labeler	Product NDC
nilotinib	Nilotinib 200 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-239
nilotinib	Nilotinib 50 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-237
nilotinib	Nilotinib 150 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-238
nilotinib	Nilotinib 150 mg/1	CapsuleOral	AvKARE	73190-033