FDA.reportPublic FDA data

Nilotinib

Product NDC
76282-789
11-digit product format
762820789
Labeler code
76282
Product ID
76282-789_dbdd9603-ecc5-472c-8ce9-7cec9aae11f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS INC.
Application
NDA218922
Marketing category
NDA
Marketing start
2025-11-14
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
Rxcui2715459, 2715469, 2715473

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
76282-789-45Nilotinib7 in 1 BLISTER PACKCAPSULE71
76282-789-46Nilotinib4 in 1 CARTONCAPSULE41
76282-789-58Nilotinib4 in 1 CARTONCAPSULE41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-789-45EA - Each76282-7895e04e292-6d03-4bb6-96c0-0ce9eea3a98212025-12-16
76282-789-58EA - Each76282-7899ad71313-6761-47ee-a880-a6538b04869e12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715469nilotinib d-tartrate 150 MG Oral CapsulePSN3c67b81f-9a44-446a-a24f-bbecbbf889791
2715473nilotinib d-tartrate 200 MG Oral CapsulePSN3c67b81f-9a44-446a-a24f-bbecbbf889791
2715459nilotinib d-tartrate 50 MG Oral CapsulePSN3c67b81f-9a44-446a-a24f-bbecbbf889791
2715469nilotinib d-tartrate 150 MG Oral CapsuleSCD3c67b81f-9a44-446a-a24f-bbecbbf889791
2715473nilotinib d-tartrate 200 MG Oral CapsuleSCD3c67b81f-9a44-446a-a24f-bbecbbf889791
2715459nilotinib d-tartrate 50 MG Oral CapsuleSCD3c67b81f-9a44-446a-a24f-bbecbbf889791
2715469nilotinib 150 MG (as nilotinib d-tartrate 192.517 MG) Oral CapsuleSY3c67b81f-9a44-446a-a24f-bbecbbf889791
2715473nilotinib 200 MG (as nilotinib d-tartrate 256.689 MG) Oral CapsuleSY3c67b81f-9a44-446a-a24f-bbecbbf889791
2715459nilotinib 50 MG (as nilotinib d-tartrate 64.172 MG) Oral CapsuleSY3c67b81f-9a44-446a-a24f-bbecbbf889791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-789-45762820789457 in 1 BLISTER PACKHistorical
76282-789-46762820789464 in 1 CARTONHistorical
76282-789-58762820789584 CARTON in 1 CARTON (76282-789-58) / 4 BLISTER PACK in 1 CARTON (76282-789-46) / 7 CAPSULE in 1 BLISTER PACK (76282-789-45) 4 carton2025-11-14NoNoCurrent