Nilotinib

Product NDC: 69097-032
Requested package NDC: 69097-032-74
11-digit product format: 690970032
Labeler code: 69097
Product ID: 69097-032_7c40f411-8579-4c45-a820-3b79926a932f
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
Marketing end: 2027-04-30
Substance: NILOTINIB
Active strength: 200 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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	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
2026-09-14 22:38:34	2026-08	N218922-001	NILOTINIB D-TARTRATE	EQ 50MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218922-002	NILOTINIB D-TARTRATE	EQ 150MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218922-003	NILOTINIB D-TARTRATE	EQ 200MG BASE	CAPSULE / ORAL	RLD	2025-02-19	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nilotinib

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NILOTINIB	200 mg/1

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
69097-032-17	Nilotinib	7 in 1 BLISTER PACK	CAPSULE	7	5
69097-032-56	Nilotinib	4 in 1 CARTON	CAPSULE	4	5
69097-032-73	Nilotinib	2 in 1 CARTON	CAPSULE	2	5
69097-032-74	Nilotinib	4 in 1 CARTON	CAPSULE	4	5
69097-032-76	Nilotinib	14 in 1 BLISTER PACK	CAPSULE	14	5
69097-032-91	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
69097-032-17	EA - Each	69097-032	c2ae98e6-3649-4fb6-9eb4-eff5afa06ef0	1	2025-12-16
69097-032-56	EA - Each	69097-032	a4b8e6e5-38c6-4bde-a579-5f3ceee2e748	1	2025-07-08
69097-032-74	EA - Each	69097-032	43e10b8d-6a98-4657-b5b2-cbe3b802a5ca	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 (package): 69097-032-74 ndc (product): 69097-032 ndc11 (package): 69097003274

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	Marketing end	Sample	Exclude flag	Status
69097-032-74	69097003274	4 CARTON in 1 CARTON (69097-032-74) / 4 BLISTER PACK in 1 CARTON (69097-032-56) / 7 CAPSULE in 1 BLISTER PACK (69097-032-17)	4 carton	2025-06-18	2027-04-30	No	No	Historical

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	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	6