What is NDC 13668-710?

13668-710 is the product NDC for nilotinib, Nilotinib hydrochloride monohydrate 150 mg/1 capsule, listed with the FDA by Torrent Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Nilotinib hydrochloride monohydrate.

Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 13668-710 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-710Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0710Add 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
13668-710-57	1366807105713668071057	4 BLISTER PACK in 1 CARTON (13668-710-57) / 28 CAPSULE in 1 BLISTER PACKMarketed from Dec 16, 2025
13668-710-91	1366807109113668071091	1 BLISTER PACK in 1 CARTON (13668-710-91) / 28 CAPSULE in 1 BLISTER PACKMarketed from Dec 16, 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 — 150 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218532
Marketing start: Dec 16, 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 13668-710_1160ea15-94e0-4555-a86b-7eee9ef4d859SPL ID 1160ea15-94e0-4555-a86b-7eee9ef4d859SPL set ID b34e7fd4-53c5-46d8-bf8a-1fcbe7a16504RxCUI 746606, 997653UNII 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

N413668071057 followed by a unit qualifier and the quantity

Package 13668-0710-57. 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 Aug 31, 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)

About NDC 13668-710

What is NDC 13668-710?: 13668-710 is the product NDC for nilotinib, Nilotinib hydrochloride monohydrate 150 mg/1 capsule, listed with the FDA by Torrent Pharmaceuticals Limited. 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 hydrochloride monohydrate.
Who is the labeler?: Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 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
nilotinib	Nilotinib 150 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-238	72205-0238-6372205-0238-64

All 18 nilotinib NDCs

Other NDCs under ANDA 218532

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

FDA NDC Directory listings under ANDA 218532
Product	Strength	Form · route	Labeler	Product NDC
nilotinib	Nilotinib hydrochloride monohydrate 200 mg/1	CapsuleOral	Torrent Pharmaceuticals Limited	13668-711