What is NDC 69097-031?

69097-031 is the product NDC for Nilotinib, Nilotinib 150 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-031 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0031Add 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
69097-031-74	6909700317469097003174	4 CARTON in 1 CARTON (69097-031-74) / 4 BLISTER PACK in 1 CARTON (69097-031-56) / 7 CAPSULE in 1 BLISTER PACK (69097-031-17)Marketed from Jun 18, 2025
69097-031-91	6909700319169097003191	4 CARTON in 1 CARTON (69097-031-91) / 2 BLISTER PACK in 1 CARTON (69097-031-73) / 14 CAPSULE in 1 BLISTER PACK (69097-031-76)Marketed from Jun 18, 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: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 218922
Marketing start: Jun 18, 2025
Marketing end: Apr 30, 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 69097-031_7c40f411-8579-4c45-a820-3b79926a932fSPL ID 7c40f411-8579-4c45-a820-3b79926a932f
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

N469097003174 followed by a unit qualifier and the quantity

Package 69097-0031-74. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 69097-031

What is NDC 69097-031?: 69097-031 is the product NDC for Nilotinib, Nilotinib 150 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, 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?: Cipla USA Inc., NDC labeler code 69097. 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 NDA 218922

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

FDA NDC Directory listings under NDA 218922
Product	Strength	Form · route	Labeler	Product NDC
Nilotinib	Nilotinib 50 mg/1	CapsuleOral	Cipla USA Inc.	69097-030
Nilotinib	Nilotinib 200 mg/1	CapsuleOral	Cipla USA Inc.	69097-032