FDA.reportPublic FDA data

Sunitinib Malate

Product NDC
72205-117
11-digit product format
722050117
Labeler code
72205
Product ID
72205-117_15dd0555-b33f-4f56-94d3-0f4ce888df01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sunitinib Malate
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214824
Marketing category
ANDA
Marketing start
2025-02-14
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
A214824-001SUNITINIB MALATESUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2025-02-14
A214824-002SUNITINIB MALATESUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2025-02-14
A214824-003SUNITINIB MALATESUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2025-02-14
A214824-004SUNITINIB MALATESUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2025-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214824-001AB
A214824-002AB
A214824-003AB
A214824-004AB

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 22:54:322026-06A214824-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2025-02-14a50c72e98297…
2026-08-01 22:54:322026-06A214824-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2025-02-14a50c72e98297…
2026-08-01 22:54:322026-06A214824-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2025-02-14a50c72e98297…
2026-08-01 22:54:322026-06A214824-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2025-02-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214824-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214824-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A214824-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A214824-004AB1a50c72e98297…

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 MALATENovadoz Pharmaceuticals LLC15dd0555-b33f-4f56-94d3-0f4ce888df012025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214824
application number: ANDA214824
ndc (product): 72205-117

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
15dd0555-b33f-4f56-94d3-0f4ce888df01Available on FDA.report

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
72205-117-28Sunitinib Malate28 in 1 BOTTLECAPSULE281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-117-28EA - Each72205-117b45eda2b-954d-47e3-b9fd-0b775dde5f7612025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN15dd0555-b33f-4f56-94d3-0f4ce888df011
616285SUNItinib malate 25 MG Oral CapsulePSN15dd0555-b33f-4f56-94d3-0f4ce888df011
1541890SUNItinib malate 37.5 MG Oral CapsulePSN15dd0555-b33f-4f56-94d3-0f4ce888df011
616289SUNItinib malate 50 MG Oral CapsulePSN15dd0555-b33f-4f56-94d3-0f4ce888df011
616279sunitinib 12.5 MG Oral CapsuleSCD15dd0555-b33f-4f56-94d3-0f4ce888df011
616285sunitinib 25 MG Oral CapsuleSCD15dd0555-b33f-4f56-94d3-0f4ce888df011
1541890sunitinib 37.5 MG Oral CapsuleSCD15dd0555-b33f-4f56-94d3-0f4ce888df011
616289sunitinib 50 MG Oral CapsuleSCD15dd0555-b33f-4f56-94d3-0f4ce888df011
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY15dd0555-b33f-4f56-94d3-0f4ce888df011
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY15dd0555-b33f-4f56-94d3-0f4ce888df011
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY15dd0555-b33f-4f56-94d3-0f4ce888df011
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY15dd0555-b33f-4f56-94d3-0f4ce888df011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-117-287220501172828 CAPSULE in 1 BOTTLE (72205-117-28) 28 capsule2025-06-01NoNoCurrent