Sunitinib Malate

Product NDC
82293-015
11-digit product format
822930015
Labeler code
82293
Product ID
82293-015_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
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 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-001SUNITINIB MALATEEQ 12.5MG BASECAPSULE / ORALAB2023-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-002SUNITINIB MALATEEQ 25MG BASECAPSULE / ORALAB2023-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-003SUNITINIB MALATEEQ 37.5MG BASECAPSULE / ORALAB2023-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-004SUNITINIB MALATEEQ 50MG BASECAPSULE / ORALAB2023-08-21d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218012-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218012-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218012-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218012-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218012-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218012-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218012-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218012-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218012-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218012-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218012-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218012-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218012-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218012-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218012-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218012-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218012-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218012-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218012-004AB1d8e5a09893c0…

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
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
82293-015-10Sunitinib Malate28 in 1 BOTTLECAPSULE282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-015-10EA - Each82293-0150f9ac583-e8b7-4409-b2e0-2ef64848292f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-015SUNITINIB MALATE CAPSULE [NOVUGEN PHARMA (USA) LLC.]2Current NDC, 1 package rows20240912_04d34bce-1296-d2b9-e063-6394a90a7018.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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): 82293-015

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
82293-015-108229300151028 CAPSULE in 1 BOTTLE (82293-015-10) 28 capsule2024-05-01NoNoCurrent