FDA.reportPublic FDA data

Nilotinib

Product NDC
60505-3801
11-digit product format
605053801
Labeler code
60505
Product ID
60505-3801_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
150 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
NILOTINIB150 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
60505-3801-0Nilotinib14 in 1 BLISTER PACKCAPSULE149
60505-3801-0Nilotinib2 in 1 CARTONCAPSULE29
60505-3801-2Nilotinib4 in 1 CARTONCAPSULE49
60505-3801-3Nilotinib2 in 1 CARTONCAPSULE29
60505-3801-3Nilotinib14 in 1 BLISTER PACKCAPSULE149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3801-0EA - Each60505-3801ae57a796-70c6-4313-acce-69c653a92f4812025-06-13
60505-3801-2EA - Each60505-3801c19dbb10-3041-499c-84c7-5f912fa191c612025-06-13
60505-3801-3EA - Each60505-38017c5d003a-fa80-4bc4-976d-94b7dea9e50112025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3801NILOTINIB 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
60505-3801-0605053801002 BLISTER PACK in 1 CARTON (60505-3801-0) / 14 CAPSULE in 1 BLISTER PACK2 blister pack2025-05-23NoNoHistorical
60505-3801-2605053801024 CARTON in 1 CARTON (60505-3801-2) / 2 BLISTER PACK in 1 CARTON (60505-3801-3) / 14 CAPSULE in 1 BLISTER PACK4 carton2025-05-23NoNoHistorical
60505-3801-3605053801032 in 1 CARTONHistorical