FDA.reportPublic FDA data

Sunitinib Malate

Product NDC
0378-6678
11-digit product format
003786678
Labeler code
0378
Product ID
0378-6678_9e441770-fe62-43c0-b293-7ebc8f753ebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sunitinib malate
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201275
Marketing category
ANDA
Marketing start
2022-01-04
Substance
SUNITINIB MALATE
Active strength
12.5 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
A201275-001SUNITINIB MALATESUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-12-06
A201275-002SUNITINIB MALATESUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-12-06
A201275-003SUNITINIB MALATESUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-12-06
A201275-004SUNITINIB MALATESUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201275-001AB
A201275-002AB
A201275-003AB
A201275-004AB

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 22:54:322026-06A201275-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-12-06a50c72e98297…
2026-08-01 22:54:322026-06A201275-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-12-06a50c72e98297…
2026-08-01 22:54:322026-06A201275-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-12-06a50c72e98297…
2026-08-01 22:54:322026-06A201275-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-12-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201275-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A201275-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A201275-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A201275-004AB1a50c72e98297…

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 MALATEMylan Pharmaceuticals Inc.4dbfcc02-dacc-4f0c-9f41-095783b68e272023-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201275
application number: ANDA201275
ndc (product): 0378-6678

Additional Listing Data#

Finished product
Yes
Brand name base
Sunitinib Malate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUNITINIB MALATE12.5 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
4dbfcc02-dacc-4f0c-9f41-095783b68e27Available 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
0378-6678-28Sunitinib Malate28 in 1 BOTTLE, PLASTICCAPSULE283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6678-28EA - Each0378-66788c53a3a2-51b3-4ed9-96cf-7f96fe27706b12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6678SUNITINIB MALATE CAPSULE [MYLAN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20240508_4dbfcc02-dacc-4f0c-9f41-095783b68e27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN4dbfcc02-dacc-4f0c-9f41-095783b68e273
616285SUNItinib malate 25 MG Oral CapsulePSN4dbfcc02-dacc-4f0c-9f41-095783b68e273
1541890SUNItinib malate 37.5 MG Oral CapsulePSN4dbfcc02-dacc-4f0c-9f41-095783b68e273
616289SUNItinib malate 50 MG Oral CapsulePSN4dbfcc02-dacc-4f0c-9f41-095783b68e273
616279sunitinib 12.5 MG Oral CapsuleSCD4dbfcc02-dacc-4f0c-9f41-095783b68e273
616285sunitinib 25 MG Oral CapsuleSCD4dbfcc02-dacc-4f0c-9f41-095783b68e273
1541890sunitinib 37.5 MG Oral CapsuleSCD4dbfcc02-dacc-4f0c-9f41-095783b68e273
616289sunitinib 50 MG Oral CapsuleSCD4dbfcc02-dacc-4f0c-9f41-095783b68e273
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY4dbfcc02-dacc-4f0c-9f41-095783b68e273
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY4dbfcc02-dacc-4f0c-9f41-095783b68e273
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY4dbfcc02-dacc-4f0c-9f41-095783b68e273
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY4dbfcc02-dacc-4f0c-9f41-095783b68e273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6678-280037866782828 CAPSULE in 1 BOTTLE, PLASTIC (0378-6678-28) 28 capsule2022-01-040000-00-00NoNoCurrent