FDA.reportPublic FDA data

Nilotinib

Product NDC
60505-3802
11-digit product format
605053802
Labeler code
60505
Product ID
60505-3802_6c941626-eccb-8cc5-eea9-cf3bc4ee3f0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA203640
Marketing category
ANDA
Marketing start
2025-05-23
Substance
NILOTINIB
Active strength
200 mg/1
Pharmacologic classes
Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 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
Nilotinib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NILOTINIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF41401512X
Rxcui746606, 997653, 2002717

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4599f563-25de-4179-afcc-1a2b06808025Product name120251121
ab6075cd-4ff3-41c7-b0ee-ce177f78fd3cProduct name120250716
28746c76-8e5b-45eb-989c-67bf0a789c1bProduct name220180606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3802-0Nilotinib14 in 1 BLISTER PACKCAPSULE149
60505-3802-0Nilotinib2 in 1 CARTONCAPSULE29
60505-3802-2Nilotinib4 in 1 CARTONCAPSULE49
60505-3802-3Nilotinib14 in 1 BLISTER PACKCAPSULE149
60505-3802-3Nilotinib2 in 1 CARTONCAPSULE29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3802-0EA - Each60505-380260b509bc-c7b7-4516-9035-e89f8fdeaa4912025-06-13
60505-3802-2EA - Each60505-3802dd680300-9202-4de8-a8d1-04b2646e29b612025-06-13
60505-3802-3EA - Each60505-380263230272-d2df-4093-8132-279dcd372ee412025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3802NILOTINIB CAPSULE [APOTEX CORP.]4Current NDC, 5 package rows20250525_8283672c-619f-fe60-3d25-040f95ac1440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997653nilotinib 150 MG Oral CapsulePSN8283672c-619f-fe60-3d25-040f95ac14409
746606nilotinib 200 MG Oral CapsulePSN8283672c-619f-fe60-3d25-040f95ac14409
2002717nilotinib 50 MG Oral CapsulePSN8283672c-619f-fe60-3d25-040f95ac14409
997653nilotinib 150 MG Oral CapsuleSCD8283672c-619f-fe60-3d25-040f95ac14409
746606nilotinib 200 MG Oral CapsuleSCD8283672c-619f-fe60-3d25-040f95ac14409
2002717nilotinib 50 MG Oral CapsuleSCD8283672c-619f-fe60-3d25-040f95ac14409
997653nilotinib (as nilotinib HCl) 150 MG Oral CapsuleSY8283672c-619f-fe60-3d25-040f95ac14409
746606nilotinib (as nilotinib HCl) 200 MG Oral CapsuleSY8283672c-619f-fe60-3d25-040f95ac14409
2002717nilotinib (as nilotinib hydrochloride) 50 MG Oral CapsuleSY8283672c-619f-fe60-3d25-040f95ac14409

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-3802-0605053802002 BLISTER PACK in 1 CARTON (60505-3802-0) / 14 CAPSULE in 1 BLISTER PACK2 blister pack2025-05-23NoNoHistorical
60505-3802-2605053802024 CARTON in 1 CARTON (60505-3802-2) / 2 BLISTER PACK in 1 CARTON (60505-3802-3) / 14 CAPSULE in 1 BLISTER PACK4 carton2025-05-23NoNoHistorical
60505-3802-36050538020314 in 1 BLISTER PACKHistorical