FDA.reportPublic FDA data

Sunitinib Malate

Product NDC
0093-8199
11-digit product format
000938199
Labeler code
0093
Product ID
0093-8199_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
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
A213803-001SUNITINIB MALATESUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-11-30
A213803-002SUNITINIB MALATESUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-11-30
A213803-003SUNITINIB MALATESUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-11-30
A213803-004SUNITINIB MALATESUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213803-001AB
A213803-002AB
A213803-003AB
A213803-004AB

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 22:54:322026-06A213803-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2021-11-30a50c72e98297…
2026-08-01 22:54:322026-06A213803-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2021-11-30a50c72e98297…
2026-08-01 22:54:322026-06A213803-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2021-11-30a50c72e98297…
2026-08-01 22:54:322026-06A213803-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2021-11-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213803-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213803-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213803-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A213803-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunitinib MalateSUNITINIB MALATEAvKARE0772eb61-ca42-39de-e063-6294a90a66322026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213803
application number: ANDA213803
Sunitinib MalateSUNITINIB MALATETeva Pharmaceuticals USA, Inc.a9479e5f-914f-46ca-95c1-327c66457e472025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213803
application number: ANDA213803
ndc (product): 0093-8199

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
a9479e5f-914f-46ca-95c1-327c66457e47Available 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
0093-8199-28Sunitinib Malate28 in 1 BOTTLECAPSULE284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8199-28EA - Each0093-81995e5529d1-f2f1-407c-8e5f-1dec6613166912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8199SUNITINIB 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
0093-8199-280009381992828 CAPSULE in 1 BOTTLE (0093-8199-28) 28 capsule2021-12-220000-00-00NoNoCurrent