DASATINIB

Product NDC: 72603-925
Requested package NDC: 72603-925-01
11-digit product format: 726030925
Labeler code: 72603
Product ID: 72603-925_adb28e02-69ee-4db4-a416-1f9d9ba716eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DASATINIB
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA216261
Marketing category: ANDA
Marketing start: 2026-06-01
Substance: DASATINIB
Active strength: 80 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216261-001	DASATINIB	DASATINIB	20MG	TABLET / ORAL	AB	2025-11-06
A216261-002	DASATINIB	DASATINIB	50MG	TABLET / ORAL	AB	2025-11-06
A216261-003	DASATINIB	DASATINIB	70MG	TABLET / ORAL	AB	2025-11-06
A216261-004	DASATINIB	DASATINIB	80MG	TABLET / ORAL	AB	2025-11-06
A216261-005	DASATINIB	DASATINIB	100MG	TABLET / ORAL	AB	2025-11-06
A216261-006	DASATINIB	DASATINIB	140MG	TABLET / ORAL	AB	2025-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A216261-001	AB
A216261-002	AB
A216261-003	AB
A216261-004	AB
A216261-005	AB
A216261-006	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216261-001	DASATINIB	20MG	TABLET / ORAL	AB	2025-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-002	DASATINIB	50MG	TABLET / ORAL	AB	2025-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-003	DASATINIB	70MG	TABLET / ORAL	AB	2025-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-004	DASATINIB	80MG	TABLET / ORAL	AB	2025-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-005	DASATINIB	100MG	TABLET / ORAL	AB	2025-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-006	DASATINIB	140MG	TABLET / ORAL	AB	2025-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216261-001	DASATINIB	20MG	TABLET / ORAL	AB	2025-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-002	DASATINIB	50MG	TABLET / ORAL	AB	2025-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-003	DASATINIB	70MG	TABLET / ORAL	AB	2025-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-004	DASATINIB	80MG	TABLET / ORAL	AB	2025-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-005	DASATINIB	100MG	TABLET / ORAL	AB	2025-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-006	DASATINIB	140MG	TABLET / ORAL	AB	2025-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216261-001	DASATINIB	20MG	TABLET / ORAL	AB	2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-002	DASATINIB	50MG	TABLET / ORAL	AB	2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-003	DASATINIB	70MG	TABLET / ORAL	AB	2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-004	DASATINIB	80MG	TABLET / ORAL	AB	2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-005	DASATINIB	100MG	TABLET / ORAL	AB	2025-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-006	DASATINIB	140MG	TABLET / ORAL	AB	2025-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-001	DASATINIB	20MG	TABLET / ORAL	AB	2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-002	DASATINIB	50MG	TABLET / ORAL	AB	2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-003	DASATINIB	70MG	TABLET / ORAL	AB	2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-004	DASATINIB	80MG	TABLET / ORAL	AB	2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-005	DASATINIB	100MG	TABLET / ORAL	AB	2025-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-006	DASATINIB	140MG	TABLET / ORAL	AB	2025-11-06	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-001	DASATINIB	20MG	TABLET / ORAL	AB	2025-11-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-002	DASATINIB	50MG	TABLET / ORAL	AB	2025-11-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-003	DASATINIB	70MG	TABLET / ORAL	AB	2025-11-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-004	DASATINIB	80MG	TABLET / ORAL	AB	2025-11-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-005	DASATINIB	100MG	TABLET / ORAL	AB	2025-11-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-006	DASATINIB	140MG	TABLET / ORAL	AB	2025-11-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216261-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216261-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216261-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216261-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216261-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216261-006	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216261-006	AB	1	`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: DASATINIB
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DASATINIB	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RBZ1571X5H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
643105	Internal RxNorm lookup
643107	Internal RxNorm lookup
643109	Internal RxNorm lookup
799047	Internal RxNorm lookup
1045402	Internal RxNorm lookup
1045406	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
f9b79d54-9bee-4c93-9c87-f3e65d91f146	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b66e60ef-563e-ddb8-43b4-d625943af44b	Product name	3	20251209
820d87d5-5779-4353-ae7e-33904df346a1	Product name	1	20241218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72603-925-01	DASATINIB	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DASATINIB	DASATINIB	NorthStar RxLLC	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216261 application number: ANDA216261 ndc (package): 72603-925-01 ndc (product): 72603-925 ndc11 (package): 72603092501
DASATINIB	DASATINIB	Alembic Pharmaceuticals Limited	645fcf26-1b2f-40c5-881b-8effe02defbd	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216261 application number: ANDA216261
DASATINIB	DASATINIB	Alembic Pharmaceuticals Inc.	de3215a4-d098-4bc3-ad81-c7c9e3493872	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216261 application number: ANDA216261

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RBZ1571X5H	DASATINIB	863127-77-9	DASATINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
799047	dasatinib 100 MG Oral Tablet	PSN	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
1045402	dasatinib 140 MG Oral Tablet	PSN	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
643105	dasatinib 20 MG Oral Tablet	PSN	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
643107	dasatinib 50 MG Oral Tablet	PSN	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
643109	dasatinib 70 MG Oral Tablet	PSN	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
1045406	dasatinib 80 MG Oral Tablet	PSN	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
799047	dasatinib 100 MG Oral Tablet	SCD	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
1045402	dasatinib 140 MG Oral Tablet	SCD	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
643105	dasatinib 20 MG Oral Tablet	SCD	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
643107	dasatinib 50 MG Oral Tablet	SCD	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
643109	dasatinib 70 MG Oral Tablet	SCD	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2
1045406	dasatinib 80 MG Oral Tablet	SCD	f9b79d54-9bee-4c93-9c87-f3e65d91f146	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72603-925-01	72603092501	30 TABLET, FILM COATED in 1 BOTTLE (72603-925-01)	2026-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DASATINIB	NorthStar RxLLC \| Alembic Pharmaceuticals Limited	2026-05-28	Human Prescription Drug Label	2