Nilotinib NDC 43598-456

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-456Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0456Add 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
43598-456-46	43598045646	8 BLISTER PACK in 1 CARTON (43598-456-46) / 14 CAPSULE in 1 BLISTER PACK (43598-456-74)Marketed 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 hydrochloride monohydrate — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218350
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 43598-456_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5SPL ID 0e4d3a09-2813-d066-3d1b-2a7e0b196fd5SPL set ID 805cc504-60bb-7743-5ada-679eb3badc7fRxCUI 746606, 997653, 2002717UNII 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

N443598045646 followed by a unit qualifier and the quantity

Package 43598-0456-46. 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

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