FDA.reportPublic FDA data

Sunitinib Malate

Product NDC
82293-017
11-digit product format
822930017
Labeler code
82293
Product ID
82293-017_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
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

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
A218012-001SUNITINIB MALATESUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21
A218012-002SUNITINIB MALATESUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21
A218012-003SUNITINIB MALATESUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21
A218012-004SUNITINIB MALATESUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218012-001AB
A218012-002AB
A218012-003AB
A218012-004AB

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 22:54:322026-06A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21a50c72e98297…
2026-08-01 22:54:322026-06A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21a50c72e98297…
2026-08-01 22:54:322026-06A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21a50c72e98297…
2026-08-01 22:54:322026-06A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218012-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218012-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A218012-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A218012-004AB1a50c72e98297…

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 MALATENovugen Pharma (USA) LLC.04d34bce-1296-d2b9-e063-6394a90a70182024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218012
application number: ANDA218012
ndc (product): 82293-017

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 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
04d34bce-1296-d2b9-e063-6394a90a7018Available 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
82293-017-10Sunitinib Malate28 in 1 BOTTLECAPSULE282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-017-10EA - Each82293-0170a5f001c-7ad0-4e51-99cd-b60987b8338c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-017SUNITINIB 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
82293-017-108229300171028 CAPSULE in 1 BOTTLE (82293-017-10) 28 capsule2024-05-01NoNoCurrent