FDA.reportPublic FDA data

SUNITINIB MALATE

Product NDC
59651-465
11-digit product format
596510465
Labeler code
59651
Product ID
59651-465_a3d2b07e-f9d2-4f17-9a80-025d77ff8f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUNITINIB MALATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218615
Marketing category
ANDA
Marketing start
2024-03-14
Substance
SUNITINIB MALATE
Active strength
25 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218615-001SUNITINIB MALATESUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2024-03-14
A218615-002SUNITINIB MALATESUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2024-03-14
A218615-003SUNITINIB MALATESUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2024-03-14
A218615-004SUNITINIB MALATESUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2024-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218615-001AB
A218615-002AB
A218615-003AB
A218615-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A218615-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2024-03-14a50c72e98297…
2026-08-01 22:54:322026-06A218615-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2024-03-14a50c72e98297…
2026-08-01 22:54:322026-06A218615-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2024-03-14a50c72e98297…
2026-08-01 22:54:322026-06A218615-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2024-03-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218615-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218615-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A218615-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A218615-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNITINIB MALATESUNITINIB MALATEAurobindo Pharma Limited810dfcb2-d35b-4971-887c-2e78e82e9e072025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218615
application number: ANDA218615
ndc (product): 59651-465

Additional Listing Data#

Finished product
Yes
Brand name base
SUNITINIB MALATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUNITINIB MALATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LVX8N1UT73Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616279Internal RxNorm lookup
616285Internal RxNorm lookup
616289Internal RxNorm lookup
1541890Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
810dfcb2-d35b-4971-887c-2e78e82e9e07Available on FDA.report

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
59651-465-28SUNITINIB MALATE28 in 1 BOTTLECAPSULE282
59651-465-29SUNITINIB MALATE7 in 1 BLISTER PACKCAPSULE72
59651-465-29SUNITINIB MALATE4 in 1 CARTONCAPSULE42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-465-28EA - Each59651-465a25844e5-8150-4a16-8d08-d76a7f0c0c6612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-465SUNITINIB MALATE CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 3 package rows20250419_810dfcb2-d35b-4971-887c-2e78e82e9e07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN810dfcb2-d35b-4971-887c-2e78e82e9e072
616285SUNItinib malate 25 MG Oral CapsulePSN810dfcb2-d35b-4971-887c-2e78e82e9e072
1541890SUNItinib malate 37.5 MG Oral CapsulePSN810dfcb2-d35b-4971-887c-2e78e82e9e072
616289SUNItinib malate 50 MG Oral CapsulePSN810dfcb2-d35b-4971-887c-2e78e82e9e072
616279sunitinib 12.5 MG Oral CapsuleSCD810dfcb2-d35b-4971-887c-2e78e82e9e072
616285sunitinib 25 MG Oral CapsuleSCD810dfcb2-d35b-4971-887c-2e78e82e9e072
1541890sunitinib 37.5 MG Oral CapsuleSCD810dfcb2-d35b-4971-887c-2e78e82e9e072
616289sunitinib 50 MG Oral CapsuleSCD810dfcb2-d35b-4971-887c-2e78e82e9e072
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY810dfcb2-d35b-4971-887c-2e78e82e9e072
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY810dfcb2-d35b-4971-887c-2e78e82e9e072
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY810dfcb2-d35b-4971-887c-2e78e82e9e072
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY810dfcb2-d35b-4971-887c-2e78e82e9e072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-465-285965104652828 CAPSULE in 1 BOTTLE (59651-465-28) 28 capsule2024-03-14NoNoCurrent
59651-465-29596510465294 BLISTER PACK in 1 CARTON (59651-465-29) / 7 CAPSULE in 1 BLISTER PACK4 blister pack2024-03-14NoNoCurrent