FDA.reportPublic FDA data

nilotinib

Product NDC
72205-239
11-digit product format
722050239
Labeler code
72205
Product ID
72205-239_13b46e09-62d2-4ce9-b3c0-deafcb1f1842
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218544
Marketing category
ANDA
Marketing start
2025-11-19
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
72205-239-63nilotinib28 in 1 BLISTER PACKCAPSULE281
72205-239-64nilotinib28 in 1 BLISTER PACKCAPSULE281
72205-239-64nilotinib4 in 1 CARTONCAPSULE41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-239-63EA - Each72205-239ba42eab0-fcb0-49e4-b075-d8ce523d9af612025-12-16
72205-239-64EA - Each72205-239f85f4f92-b813-437e-aed8-9015cf3a041312025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997653nilotinib 150 MG Oral CapsulePSN13b46e09-62d2-4ce9-b3c0-deafcb1f18421
746606nilotinib 200 MG Oral CapsulePSN13b46e09-62d2-4ce9-b3c0-deafcb1f18421
2002717nilotinib 50 MG Oral CapsulePSN13b46e09-62d2-4ce9-b3c0-deafcb1f18421
997653nilotinib 150 MG Oral CapsuleSCD13b46e09-62d2-4ce9-b3c0-deafcb1f18421
746606nilotinib 200 MG Oral CapsuleSCD13b46e09-62d2-4ce9-b3c0-deafcb1f18421
2002717nilotinib 50 MG Oral CapsuleSCD13b46e09-62d2-4ce9-b3c0-deafcb1f18421
997653nilotinib (as nilotinib HCl) 150 MG Oral CapsuleSY13b46e09-62d2-4ce9-b3c0-deafcb1f18421
746606nilotinib (as nilotinib HCl) 200 MG Oral CapsuleSY13b46e09-62d2-4ce9-b3c0-deafcb1f18421
2002717nilotinib (as nilotinib hydrochloride) 50 MG Oral CapsuleSY13b46e09-62d2-4ce9-b3c0-deafcb1f18421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-239-637220502396328 CAPSULE in 1 BLISTER PACK (72205-239-63) 28 capsule2025-11-20NoNoCurrent
72205-239-64722050239644 BLISTER PACK in 1 CARTON (72205-239-64) / 28 CAPSULE in 1 BLISTER PACK4 blister pack2025-11-20NoNoCurrent