DANZITEN

Product NDC: 24338-155
11-digit product format: 243380155
Labeler code: 24338
Product ID: 24338-155_62029a35-74af-47bc-9b7b-93dcaddfd278
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nilotinib
Dosage form: TABLET
Route: ORAL
Labeler: Azurity Pharmaceuticals, Inc.
Application: NDA219293
Marketing category: NDA
Marketing start: 2024-11-30
Substance: NILOTINIB
Active strength: 95 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219293-001	DANZITEN	NILOTINIB TARTRATE	EQ 71MG BASE	TABLET / ORAL		RLD, RS	2024-11-07
N219293-002	DANZITEN	NILOTINIB TARTRATE	EQ 95MG BASE	TABLET / ORAL		RLD, RS	2024-11-07

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N219293-001	10874671	2040-02-18	Drug product	2024-11-08
N219293-001	11793809	2040-02-18	Drug product	2024-11-08
N219293-001	12403140	2040-02-18	Drug product	2025-09-22
N219293-001	12629369	2040-02-18	Drug product	2026-06-05
N219293-002	10874671	2040-02-18	Drug product	2024-11-08
N219293-002	11793809	2040-02-18	Drug product	2024-11-08
N219293-002	12403140	2040-02-18	Drug product	2025-09-22
N219293-002	12629369	2040-02-18	Drug product	2026-06-05

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
2026-02-19 14:30 UTC	2026-02	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-001	12403140	2040-02-18	Drug product	2025-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	12403140	2040-02-18	Drug product	2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	12403140	2040-02-18	Drug product	2025-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	12403140	2040-02-18	Drug product	2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	12403140	2040-02-18	Drug product	2025-09-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	12629369	2040-02-18	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	12403140	2040-02-18	Drug product	2025-09-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	12629369	2040-02-18	Drug product	2026-06-05	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NILOTINIB	95 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2698564	Internal RxNorm lookup
2698570	Internal RxNorm lookup
2698572	Internal RxNorm lookup
2698574	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
d288d165-3505-49bb-9b2e-124490d65f49	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
28746c76-8e5b-45eb-989c-67bf0a789c1b	Product name	2	20180606
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24338-155-01	DANZITEN	4 in 1 CARTON	TABLET	4	3
24338-155-02	DANZITEN	2 in 1 CARTON	TABLET	2	3
24338-155-03	DANZITEN	14 in 1 BLISTER PACK	TABLET	14	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24338-155-01	EA - Each	24338-155	903121ed-80dc-43d7-8c45-e9562c445412	1	2024-12-10
24338-155-02	EA - Each	24338-155	2b268737-465e-4325-8902-7dbab16a3374	1	2024-12-10
24338-155-03	EA - Each	24338-155	dcba06b5-3f28-458f-8e29-3870b4432d36	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24338-155	DANZITEN (NILOTINIB) TABLET [AZURITY PHARMACEUTICALS, INC.]	2	Current NDC, 3 package rows	20241130_d288d165-3505-49bb-9b2e-124490d65f49.zip

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
DANZITEN	NILOTINIB	Azurity Pharmaceuticals, Inc.	d288d165-3505-49bb-9b2e-124490d65f49	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219293 application number: NDA219293 ndc (product): 24338-155

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
2698570	Danziten 71 MG Oral Tablet	PSN	d288d165-3505-49bb-9b2e-124490d65f49	3
2698574	Danziten 95 MG Oral Tablet	PSN	d288d165-3505-49bb-9b2e-124490d65f49	3
2698564	nilotinib 71 MG Oral Tablet	PSN	d288d165-3505-49bb-9b2e-124490d65f49	3
2698572	nilotinib 95 MG Oral Tablet	PSN	d288d165-3505-49bb-9b2e-124490d65f49	3
2698570	nilotinib 71 MG Oral Tablet [Danziten]	SBD	d288d165-3505-49bb-9b2e-124490d65f49	3
2698574	nilotinib 95 MG Oral Tablet [Danziten]	SBD	d288d165-3505-49bb-9b2e-124490d65f49	3
2698564	nilotinib 71 MG Oral Tablet	SCD	d288d165-3505-49bb-9b2e-124490d65f49	3
2698572	nilotinib 95 MG Oral Tablet	SCD	d288d165-3505-49bb-9b2e-124490d65f49	3
2698570	Danziten 71 MG (equivalent to nilotinib tartrate 91.14 MG) Oral Tablet	SY	d288d165-3505-49bb-9b2e-124490d65f49	3
2698574	Danziten 95 MG (equivalent to nilotinib tartrate 121.95 MG) Oral Tablet	SY	d288d165-3505-49bb-9b2e-124490d65f49	3
2698564	nilotinib 71 MG (equivalent to nilotinib tartrate 91.14 MG) Oral Tablet	SY	d288d165-3505-49bb-9b2e-124490d65f49	3
2698572	nilotinib 95 MG (equivalent to nilotinib tartrate 121.95 MG) Oral Tablet	SY	d288d165-3505-49bb-9b2e-124490d65f49	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
24338-155-01	24338015501	4 CARTON in 1 CARTON (24338-155-01) / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03)	4 carton	2024-11-30	No	No	Current
24338-155-02	24338015502	2 in 1 CARTON					Historical
24338-155-03	24338015503	14 in 1 BLISTER PACK					Historical