Sunitinib malate

Product NDC: 16714-676
Requested package NDC: 16714-676-01
11-digit product format: 167140676
Labeler code: 16714
Product ID: 16714-676_7579e3d0-2de6-4239-a7a8-118ed92075f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sunitinib malate
Dosage form: CAPSULE
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA213914
Marketing category: ANDA
Marketing start: 2022-02-18
Marketing end: 0000-00-00
Substance: SUNITINIB MALATE
Active strength: 13 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-676	16714-676-01	D	Discontinued by firm		2026-10-05

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213914-001	SUNITINIB MALATE	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16
A213914-002	SUNITINIB MALATE	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16
A213914-003	SUNITINIB MALATE	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16
A213914-004	SUNITINIB MALATE	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213914-001	AB
A213914-002	AB
A213914-003	AB
A213914-004	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 4 · 140 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
2026-09-14 22:38:34	2026-08	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-08-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213914-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213914-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213914-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213914-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213914-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213914-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213914-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213914-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213914-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213914-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213914-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213914-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213914-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213914-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213914-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213914-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213914-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213914-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213914-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213914-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213914-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213914-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c71c27c5-81ab-f132-824f-21f56518b6f9	Product name	3	20250516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-676-01	Sunitinib malate	28 in 1 BOTTLE	CAPSULE	28		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-676-01	EA - Each	16714-676	f32b688b-0891-4b60-9d5b-a398467e9912	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-676	SUNITINIB MALATE CAPSULE [NORTHSTAR RXLLC]	2	Legacy NDC, 1 package rows	20241228_7579e3d0-2de6-4239-a7a8-118ed92075f5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunitinib malate	SUNITINIB MALATE	NorthStar RxLLC	7579e3d0-2de6-4239-a7a8-118ed92075f5	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213914 application number: ANDA213914 ndc (package): 16714-676-01 ndc (product): 16714-676 ndc11 (package): 16714067601
Sunitinib malate	SUNITINIB MALATE	Sun Pharmaceutical Industries Inc.	06e0ad28-6637-4f54-879c-2c194aece5fd	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213914 application number: ANDA213914

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LVX8N1UT73	SUNITINIB MALATE	341031-54-7	SUNITINIB MALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616279	SUNItinib malate 12.5 MG Oral Capsule	PSN	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616285	SUNItinib malate 25 MG Oral Capsule	PSN	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
1541890	SUNItinib malate 37.5 MG Oral Capsule	PSN	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616289	SUNItinib malate 50 MG Oral Capsule	PSN	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616279	sunitinib 12.5 MG Oral Capsule	SCD	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616285	sunitinib 25 MG Oral Capsule	SCD	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
1541890	sunitinib 37.5 MG Oral Capsule	SCD	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616289	sunitinib 50 MG Oral Capsule	SCD	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616285	sunitinib (as sunitinib malate) 25 MG Oral Capsule	SY	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
1541890	sunitinib (as sunitinib malate) 37.5 MG Oral Capsule	SY	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616279	sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral Capsule	SY	7579e3d0-2de6-4239-a7a8-118ed92075f5	2
616289	sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral Capsule	SY	7579e3d0-2de6-4239-a7a8-118ed92075f5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-676-01	16714067601	28 CAPSULE in 1 BOTTLE (16714-676-01)	28 capsule	2022-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunitinib malate	NorthStar RxLLC \| Sun pharmaceutical industries Ltd.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	3