Sunitinib malate

Product NDC
16714-676
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-676DDiscontinued by firm2026-10-05
excluded packagepackage16714-67616714-676-01DDiscontinued by firm2026-10-05

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213914-001SUNITINIB MALATESUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-16
A213914-002SUNITINIB MALATESUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-16
A213914-003SUNITINIB MALATESUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-16
A213914-004SUNITINIB MALATESUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213914-001AB
A213914-002AB
A213914-003AB
A213914-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-1684e616aacf4f…
2026-09-14 22:38:342026-08A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-1684e616aacf4f…
2026-09-14 22:38:342026-08A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-1684e616aacf4f…
2026-09-14 22:38:342026-08A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-1684e616aacf4f…
2026-08-18 06:07:402026-07A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-08-165bbf6a4d5a75…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213914-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213914-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213914-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A213914-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A213914-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213914-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213914-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213914-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213914-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213914-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213914-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213914-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213914-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213914-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213914-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213914-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213914-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213914-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213914-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213914-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213914-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213914-004AB15bbf6a4d5a75…

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 conceptRelationVersionEffective
c71c27c5-81ab-f132-824f-21f56518b6f9Product name320250516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-676-01Sunitinib malate28 in 1 BOTTLECAPSULE282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-676-01EA - Each16714-676f32b688b-0891-4b60-9d5b-a398467e991212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-676SUNITINIB MALATE CAPSULE [NORTHSTAR RXLLC]2Legacy NDC, 1 package rows20241228_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunitinib malateSUNITINIB MALATENorthStar RxLLC7579e3d0-2de6-4239-a7a8-118ed92075f52026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213914
application number: ANDA213914
ndc (product): 16714-676
Sunitinib malateSUNITINIB MALATESun Pharmaceutical Industries Inc.06e0ad28-6637-4f54-879c-2c194aece5fd2024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213914
application number: ANDA213914

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN7579e3d0-2de6-4239-a7a8-118ed92075f52
616285SUNItinib malate 25 MG Oral CapsulePSN7579e3d0-2de6-4239-a7a8-118ed92075f52
1541890SUNItinib malate 37.5 MG Oral CapsulePSN7579e3d0-2de6-4239-a7a8-118ed92075f52
616289SUNItinib malate 50 MG Oral CapsulePSN7579e3d0-2de6-4239-a7a8-118ed92075f52
616279sunitinib 12.5 MG Oral CapsuleSCD7579e3d0-2de6-4239-a7a8-118ed92075f52
616285sunitinib 25 MG Oral CapsuleSCD7579e3d0-2de6-4239-a7a8-118ed92075f52
1541890sunitinib 37.5 MG Oral CapsuleSCD7579e3d0-2de6-4239-a7a8-118ed92075f52
616289sunitinib 50 MG Oral CapsuleSCD7579e3d0-2de6-4239-a7a8-118ed92075f52
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY7579e3d0-2de6-4239-a7a8-118ed92075f52
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY7579e3d0-2de6-4239-a7a8-118ed92075f52
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY7579e3d0-2de6-4239-a7a8-118ed92075f52
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY7579e3d0-2de6-4239-a7a8-118ed92075f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-676-011671406760128 CAPSULE in 1 BOTTLE (16714-676-01) 28 capsule2022-02-180000-00-00NoNoCurrent