What is NDC 60505-3803?

60505-3803 is the product NDC for Nilotinib, Nilotinib 50 mg/1 capsule, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.

Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nilotinib?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nilotinib NDC 60505-3803 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-3803Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-3803Add 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
60505-3803-7	6050538030760505380307	120 CAPSULE in 1 BOTTLE (60505-3803-7)Marketed from May 23, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Apotex Corp.NDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203640
Marketing start: May 23, 2025
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 60505-3803_613e32f2-69e7-1399-da53-ecc0ae6def94SPL ID 613e32f2-69e7-1399-da53-ecc0ae6def94SPL set ID 8283672c-619f-fe60-3d25-040f95ac1440RxCUI 746606, 997653, 2002717UNII F41401512XUPC 0360505380152, 0360505380251, 0360505380374
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

N460505380307 followed by a unit qualifier and the quantity

Package 60505-3803-07. 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 Feb 24, 2026. 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 pediatr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-3803

What is NDC 60505-3803?: 60505-3803 is the product NDC for Nilotinib, Nilotinib 50 mg/1 capsule, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nilotinib.
What is the active ingredient?: Nilotinib.
Who is the labeler?: Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nilotinib?: 17 other product NDCs are listed under this name. See all Nilotinib NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nilotinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
nilotinib	Nilotinib 150 mg/1	CapsuleOral	AvKARE	73190-033	73190-0033-1173190-0033-12
nilotinib	Nilotinib 200 mg/1	CapsuleOral	AvKARE	73190-034	73190-0034-1173190-0034-12
nilotinib	Nilotinib hydrochloride monohydrate 150 mg/1	CapsuleOral	Torrent Pharmaceuticals Limited	13668-710	13668-0710-5713668-0710-91
nilotinib	Nilotinib hydrochloride monohydrate 200 mg/1	CapsuleOral	Torrent Pharmaceuticals Limited	13668-711	13668-0711-5713668-0711-91
Nilotinib	Nilotinib 150 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-779	31722-0779-33
Nilotinib	Nilotinib 200 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-780	31722-0780-33
Nilotinib	Nilotinib hydrochloride monohydrate 50 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc	43598-055	43598-0055-04
Nilotinib	Nilotinib hydrochloride monohydrate 150 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc	43598-455	43598-0455-46
Nilotinib	Nilotinib hydrochloride monohydrate 200 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc	43598-456	43598-0456-46
nilotinib	Nilotinib 50 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-237	72205-0237-92

All 18 Nilotinib NDCs

Other NDCs under ANDA 203640

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

FDA NDC Directory listings under ANDA 203640
Product	Strength	Form · route	Labeler	Product NDC
Nilotinib	Nilotinib 150 mg/1	CapsuleOral	Apotex Corp.	60505-3801
Nilotinib	Nilotinib 200 mg/1	CapsuleOral	Apotex Corp.	60505-3802