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

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 Identifiers#

Field, Values table
FieldValues
UniiLVX8N1UT73
Rxcui616279, 616285, 616289, 1541890

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