FDA.reportPublic FDA data

Sunitinib malate

Product NDC
63304-094
11-digit product format
633040094
Labeler code
63304
Product ID
63304-094_2971c7ca-50dc-e36c-e063-6294a90a4b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sunitinib malate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries Inc.
Application
ANDA213914
Marketing category
ANDA
Marketing start
2019-12-25
Substance
SUNITINIB MALATE
Active strength
50 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 MALATE50 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
63304-094-11Sunitinib malate7 in 1 BLISTER PACKCAPSULE78
63304-094-27Sunitinib malate28 in 1 BOTTLECAPSULE288
63304-094-86Sunitinib malate4 in 1 BOXCAPSULE48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-094-27EA - Each63304-094594f2f52-631d-4da3-b24c-ace1470d811c12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-094SUNITINIB MALATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES INC.]8Current NDC, Legacy NDC, 3 package rows20241228_06e0ad28-6637-4f54-879c-2c194aece5fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN06e0ad28-6637-4f54-879c-2c194aece5fd8
616285SUNItinib malate 25 MG Oral CapsulePSN06e0ad28-6637-4f54-879c-2c194aece5fd8
1541890SUNItinib malate 37.5 MG Oral CapsulePSN06e0ad28-6637-4f54-879c-2c194aece5fd8
616289SUNItinib malate 50 MG Oral CapsulePSN06e0ad28-6637-4f54-879c-2c194aece5fd8
616279sunitinib 12.5 MG Oral CapsuleSCD06e0ad28-6637-4f54-879c-2c194aece5fd8
616285sunitinib 25 MG Oral CapsuleSCD06e0ad28-6637-4f54-879c-2c194aece5fd8
1541890sunitinib 37.5 MG Oral CapsuleSCD06e0ad28-6637-4f54-879c-2c194aece5fd8
616289sunitinib 50 MG Oral CapsuleSCD06e0ad28-6637-4f54-879c-2c194aece5fd8
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY06e0ad28-6637-4f54-879c-2c194aece5fd8
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY06e0ad28-6637-4f54-879c-2c194aece5fd8
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY06e0ad28-6637-4f54-879c-2c194aece5fd8
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY06e0ad28-6637-4f54-879c-2c194aece5fd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-094-11633040094117 in 1 BLISTER PACKHistorical
63304-094-276330400942728 CAPSULE in 1 BOTTLE (63304-094-27) 28 capsule2019-12-250000-00-00NoNoCurrent
63304-094-86633040094864 BLISTER PACK in 1 BOX (63304-094-86) / 7 CAPSULE in 1 BLISTER PACK (63304-094-11) 4 blister pack2019-12-250000-00-00NoNoCurrent