FDA.reportPublic FDA data

Sunitinib Malate

Product NDC
0093-8231
11-digit product format
000938231
Labeler code
0093
Product ID
0093-8231_20ff6da6-32c4-421d-b7b0-604a502bfcb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sunitinib Malate
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA213803
Marketing category
ANDA
Marketing start
2021-12-22
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
0093-8231-28Sunitinib Malate28 in 1 BOTTLECAPSULE284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8231-28EA - Each0093-82316d591c21-1481-428e-8ffc-c1c9133816e912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8231SUNITINIB MALATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]3Current NDC, Legacy NDC, 1 package rows20250313_a9479e5f-914f-46ca-95c1-327c66457e47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSNa9479e5f-914f-46ca-95c1-327c66457e474
616285SUNItinib malate 25 MG Oral CapsulePSNa9479e5f-914f-46ca-95c1-327c66457e474
1541890SUNItinib malate 37.5 MG Oral CapsulePSNa9479e5f-914f-46ca-95c1-327c66457e474
616289SUNItinib malate 50 MG Oral CapsulePSNa9479e5f-914f-46ca-95c1-327c66457e474
616279sunitinib 12.5 MG Oral CapsuleSCDa9479e5f-914f-46ca-95c1-327c66457e474
616285sunitinib 25 MG Oral CapsuleSCDa9479e5f-914f-46ca-95c1-327c66457e474
1541890sunitinib 37.5 MG Oral CapsuleSCDa9479e5f-914f-46ca-95c1-327c66457e474
616289sunitinib 50 MG Oral CapsuleSCDa9479e5f-914f-46ca-95c1-327c66457e474
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSYa9479e5f-914f-46ca-95c1-327c66457e474
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSYa9479e5f-914f-46ca-95c1-327c66457e474
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSYa9479e5f-914f-46ca-95c1-327c66457e474
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSYa9479e5f-914f-46ca-95c1-327c66457e474
616279SUNItinib malate 12.5 MG Oral CapsulePSN0772eb61-ca42-39de-e063-6294a90a66322
616285SUNItinib malate 25 MG Oral CapsulePSN0772eb61-ca42-39de-e063-6294a90a66322
1541890SUNItinib malate 37.5 MG Oral CapsulePSN0772eb61-ca42-39de-e063-6294a90a66322
616289SUNItinib malate 50 MG Oral CapsulePSN0772eb61-ca42-39de-e063-6294a90a66322
616279sunitinib 12.5 MG Oral CapsuleSCD0772eb61-ca42-39de-e063-6294a90a66322
616285sunitinib 25 MG Oral CapsuleSCD0772eb61-ca42-39de-e063-6294a90a66322
1541890sunitinib 37.5 MG Oral CapsuleSCD0772eb61-ca42-39de-e063-6294a90a66322
616289sunitinib 50 MG Oral CapsuleSCD0772eb61-ca42-39de-e063-6294a90a66322
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY0772eb61-ca42-39de-e063-6294a90a66322
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY0772eb61-ca42-39de-e063-6294a90a66322
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY0772eb61-ca42-39de-e063-6294a90a66322
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY0772eb61-ca42-39de-e063-6294a90a66322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8231-280009382312828 CAPSULE in 1 BOTTLE (0093-8231-28) 28 capsule2021-12-220000-00-00NoNoCurrent