Nilotinib

Product NDC: 60505-3801
Requested package NDC: 60505-3801-0
11-digit product format: 605053801
Labeler code: 60505
Product ID: 60505-3801_6c941626-eccb-8cc5-eea9-cf3bc4ee3f0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nilotinib
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA203640
Marketing category: ANDA
Marketing start: 2025-05-23
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 1.

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	TE codes	Approval date
A203640-001	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05
A203640-002	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05
A203640-003	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203640-001	AB
A203640-002	AB
A203640-003	AB

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.

Product history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203640-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203640-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-003	AB	1	`6a471c1ec25d…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203640-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203640-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203640-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203640-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203640-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203640-003	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203640-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203640-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203640-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-001	PC	2025-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-002	PC	2025-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-003	PC	2025-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203640-001	PC	2025-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-002	PC	2025-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-003	PC	2025-11-19	`6a471c1ec25d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nilotinib
Listing expiration: 2027-12-31

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
746606	Internal RxNorm lookup
997653	Internal RxNorm lookup
2002717	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
8283672c-619f-fe60-3d25-040f95ac1440	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
60505-3801-0	Nilotinib	14 in 1 BLISTER PACK	CAPSULE	14	9
60505-3801-0	Nilotinib	2 in 1 CARTON	CAPSULE	2	9
60505-3801-2	Nilotinib	4 in 1 CARTON	CAPSULE	4	9
60505-3801-3	Nilotinib	2 in 1 CARTON	CAPSULE	2	9
60505-3801-3	Nilotinib	14 in 1 BLISTER PACK	CAPSULE	14	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3801-0	EA - Each	60505-3801	ae57a796-70c6-4313-acce-69c653a92f48	1	2025-06-13
60505-3801-2	EA - Each	60505-3801	c19dbb10-3041-499c-84c7-5f912fa191c6	1	2025-06-13
60505-3801-3	EA - Each	60505-3801	7c5d003a-fa80-4bc4-976d-94b7dea9e501	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3801	NILOTINIB CAPSULE [APOTEX CORP.]	4	Current NDC, 5 package rows	20250525_8283672c-619f-fe60-3d25-040f95ac1440.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
Nilotinib	NILOTINIB	Apotex Corp.	8283672c-619f-fe60-3d25-040f95ac1440	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203640 application number: ANDA203640 ndc (package): 60505-3801-0 ndc (product): 60505-3801 ndc11 (package): 60505380100

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
997653	nilotinib 150 MG Oral Capsule	PSN	8283672c-619f-fe60-3d25-040f95ac1440	9
746606	nilotinib 200 MG Oral Capsule	PSN	8283672c-619f-fe60-3d25-040f95ac1440	9
2002717	nilotinib 50 MG Oral Capsule	PSN	8283672c-619f-fe60-3d25-040f95ac1440	9
997653	nilotinib 150 MG Oral Capsule	SCD	8283672c-619f-fe60-3d25-040f95ac1440	9
746606	nilotinib 200 MG Oral Capsule	SCD	8283672c-619f-fe60-3d25-040f95ac1440	9
2002717	nilotinib 50 MG Oral Capsule	SCD	8283672c-619f-fe60-3d25-040f95ac1440	9
997653	nilotinib (as nilotinib HCl) 150 MG Oral Capsule	SY	8283672c-619f-fe60-3d25-040f95ac1440	9
746606	nilotinib (as nilotinib HCl) 200 MG Oral Capsule	SY	8283672c-619f-fe60-3d25-040f95ac1440	9
2002717	nilotinib (as nilotinib hydrochloride) 50 MG Oral Capsule	SY	8283672c-619f-fe60-3d25-040f95ac1440	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60505-3801-0	60505380100	2 BLISTER PACK in 1 CARTON (60505-3801-0) / 14 CAPSULE in 1 BLISTER PACK	2 blister pack	2025-05-23	No	No	Historical