FDA.reportPublic FDA data

SUNITINIB MALATE

Product NDC
43598-045
11-digit product format
435980045
Labeler code
43598
Product ID
43598-045_664e6a61-82ff-5756-1fc1-9266090d901e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUNITINIB MALATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA215843
Marketing category
ANDA
Marketing start
2022-11-30
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

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 Identifiers#

Field, Values table
FieldValues
UniiLVX8N1UT73
Rxcui616279, 616285, 616289, 1541890

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c71c27c5-81ab-f132-824f-21f56518b6f9Product name320250516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-045-28SUNITINIB MALATE4 in 1 CARTONCAPSULE45
43598-045-63SUNITINIB MALATE28 in 1 BOTTLECAPSULE285
43598-045-70SUNITINIB MALATE7 in 1 BLISTER PACKCAPSULE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-045-63EA - Each43598-045971d1325-80fe-4385-a47a-7ea99db0c31d12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-045SUNITINIB MALATE CAPSULE [DR.REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 3 package rows20221230_96ce8850-b5ae-382b-8433-04949533af44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616279SUNItinib malate 12.5 MG Oral CapsulePSN96ce8850-b5ae-382b-8433-04949533af445
616285SUNItinib malate 25 MG Oral CapsulePSN96ce8850-b5ae-382b-8433-04949533af445
1541890SUNItinib malate 37.5 MG Oral CapsulePSN96ce8850-b5ae-382b-8433-04949533af445
616289SUNItinib malate 50 MG Oral CapsulePSN96ce8850-b5ae-382b-8433-04949533af445
616279sunitinib 12.5 MG Oral CapsuleSCD96ce8850-b5ae-382b-8433-04949533af445
616285sunitinib 25 MG Oral CapsuleSCD96ce8850-b5ae-382b-8433-04949533af445
1541890sunitinib 37.5 MG Oral CapsuleSCD96ce8850-b5ae-382b-8433-04949533af445
616289sunitinib 50 MG Oral CapsuleSCD96ce8850-b5ae-382b-8433-04949533af445
616285sunitinib (as sunitinib malate) 25 MG Oral CapsuleSY96ce8850-b5ae-382b-8433-04949533af445
1541890sunitinib (as sunitinib malate) 37.5 MG Oral CapsuleSY96ce8850-b5ae-382b-8433-04949533af445
616279sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral CapsuleSY96ce8850-b5ae-382b-8433-04949533af445
616289sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral CapsuleSY96ce8850-b5ae-382b-8433-04949533af445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-045-28435980045284 BLISTER PACK in 1 CARTON (43598-045-28) / 7 CAPSULE in 1 BLISTER PACK (43598-045-70) 4 blister pack2022-11-300000-00-00NoNoCurrent
43598-045-634359800456328 CAPSULE in 1 BOTTLE (43598-045-63) 28 capsule2022-11-300000-00-00NoNoCurrent
43598-045-70435980045707 in 1 BLISTER PACKHistorical