FDA.reportPublic FDA data

Sunitinib Malate

Product NDC
82293-015
11-digit product format
822930015
Labeler code
82293
Product ID
82293-015_21d0ff80-d937-abb3-e063-6394a90af4b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sunitinib Malate
Dosage form
CAPSULE
Route
ORAL
Labeler
Novugen Pharma (USA) LLC.
Application
ANDA218012
Marketing category
ANDA
Marketing start
2024-05-01
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82293-015-10Sunitinib Malate28 in 1 BOTTLECAPSULE282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-015-10EA - Each82293-0150f9ac583-e8b7-4409-b2e0-2ef64848292f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-015SUNITINIB MALATE CAPSULE [NOVUGEN PHARMA (USA) LLC.]2Current NDC, 1 package rows20240912_04d34bce-1296-d2b9-e063-6394a90a7018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN04d34bce-1296-d2b9-e063-6394a90a70182
616285SUNItinib malate 25 MG Oral CapsulePSN04d34bce-1296-d2b9-e063-6394a90a70182
1541890SUNItinib malate 37.5 MG Oral CapsulePSN04d34bce-1296-d2b9-e063-6394a90a70182
616289SUNItinib malate 50 MG Oral CapsulePSN04d34bce-1296-d2b9-e063-6394a90a70182
616279sunitinib 12.5 MG Oral CapsuleSCD04d34bce-1296-d2b9-e063-6394a90a70182
616285sunitinib 25 MG Oral CapsuleSCD04d34bce-1296-d2b9-e063-6394a90a70182
1541890sunitinib 37.5 MG Oral CapsuleSCD04d34bce-1296-d2b9-e063-6394a90a70182
616289sunitinib 50 MG Oral CapsuleSCD04d34bce-1296-d2b9-e063-6394a90a70182
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY04d34bce-1296-d2b9-e063-6394a90a70182
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY04d34bce-1296-d2b9-e063-6394a90a70182
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY04d34bce-1296-d2b9-e063-6394a90a70182
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY04d34bce-1296-d2b9-e063-6394a90a70182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82293-015-108229300151028 CAPSULE in 1 BOTTLE (82293-015-10) 28 capsule2024-05-01NoNoHistorical