Nilotinib

Product NDC: 69097-031
11-digit product format: 690970031
Labeler code: 69097
Product ID: 69097-031_d748f03e-56ba-48e2-ae13-e8e74fac55e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nilotinib
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla USA Inc.
Application: NDA218922
Marketing category: NDA
Marketing start: 2025-06-18
Substance: NILOTINIB
Active strength: 150 mg/1
Pharmacologic classes: Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N218922-001	NILOTINIB D-TARTRATE	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19
N218922-002	NILOTINIB D-TARTRATE	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19
N218922-003	NILOTINIB D-TARTRATE	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2025-02-19	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nilotinib
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NILOTINIB	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F41401512X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2715459	Internal RxNorm lookup
2715469	Internal RxNorm lookup
2715473	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e27c3e09-bc4f-4f01-be05-1c43ac72285d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4599f563-25de-4179-afcc-1a2b06808025	Product name	1	20251121
ab6075cd-4ff3-41c7-b0ee-ce177f78fd3c	Product name	1	20250716
28746c76-8e5b-45eb-989c-67bf0a789c1b	Product name	2	20180606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69097-031-17	Nilotinib	7 in 1 BLISTER PACK	CAPSULE	7	5
69097-031-56	Nilotinib	4 in 1 CARTON	CAPSULE	4	5
69097-031-73	Nilotinib	2 in 1 CARTON	CAPSULE	2	5
69097-031-74	Nilotinib	4 in 1 CARTON	CAPSULE	4	5
69097-031-76	Nilotinib	14 in 1 BLISTER PACK	CAPSULE	14	5
69097-031-91	Nilotinib	4 in 1 CARTON	CAPSULE	4	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-031-17	EA - Each	69097-031	31b15e8c-7fb5-46f6-b012-b0d6f1b39547	1	2025-12-16
69097-031-56	EA - Each	69097-031	3f36005c-b3bd-42db-8c86-fbfd656e221c	1	2025-07-08
69097-031-74	EA - Each	69097-031	04b409c9-8f4d-4264-95d6-42fdb609b0ea	1	2025-07-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nilotinib	NILOTINIB	EXELAN PHARMACEUTICALS INC.	3c67b81f-9a44-446a-a24f-bbecbbf88979	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218922 application number: NDA218922
Nilotinib	NILOTINIB	Cipla USA Inc.	e27c3e09-bc4f-4f01-be05-1c43ac72285d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218922 application number: NDA218922 ndc (product): 69097-031

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F41401512X	NILOTINIB	641571-10-0	NILOTINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2715469	nilotinib d-tartrate 150 MG Oral Capsule	PSN	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715473	nilotinib d-tartrate 200 MG Oral Capsule	PSN	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715459	nilotinib d-tartrate 50 MG Oral Capsule	PSN	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715469	nilotinib d-tartrate 150 MG Oral Capsule	SCD	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715473	nilotinib d-tartrate 200 MG Oral Capsule	SCD	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715459	nilotinib d-tartrate 50 MG Oral Capsule	SCD	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715469	nilotinib 150 MG (as nilotinib d-tartrate 192.517 MG) Oral Capsule	SY	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715473	nilotinib 200 MG (as nilotinib d-tartrate 256.689 MG) Oral Capsule	SY	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5
2715459	nilotinib 50 MG (as nilotinib d-tartrate 64.172 MG) Oral Capsule	SY	e27c3e09-bc4f-4f01-be05-1c43ac72285d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69097-031-17	69097003117	7 in 1 BLISTER PACK					Historical
69097-031-56	69097003156	4 in 1 CARTON					Historical
69097-031-73	69097003173	2 in 1 CARTON					Historical
69097-031-74	69097003174	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)	4 carton	2025-06-18	No	No	Current
69097-031-76	69097003176	14 in 1 BLISTER PACK					Historical
69097-031-91	69097003191	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)	4 carton	2025-06-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nilotinib	Cipla USA Inc. \| Cipla Limited \| CIPLA LIMITED GOA \| CIPLA LIMITED BOMMASANDRA \| Genvion Corporation	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	5