FDA.reportPublic FDA data

Nilotinib

Product NDC
43598-055
11-digit product format
435980055
Labeler code
43598
Product ID
43598-055_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA218350
Marketing category
ANDA
Marketing start
2025-11-19
Substance
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Active strength
50 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
NILOTINIB HYDROCHLORIDE MONOHYDRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5JHU0N1R6K
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
43598-055-04Nilotinib120 in 1 BOTTLECAPSULE1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-055-04EA - Each43598-0552c56169a-a235-4d85-8556-5ede5fd37a6512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997653nilotinib 150 MG Oral CapsulePSN805cc504-60bb-7743-5ada-679eb3badc7f9
746606nilotinib 200 MG Oral CapsulePSN805cc504-60bb-7743-5ada-679eb3badc7f9
2002717nilotinib 50 MG Oral CapsulePSN805cc504-60bb-7743-5ada-679eb3badc7f9
997653nilotinib 150 MG Oral CapsuleSCD805cc504-60bb-7743-5ada-679eb3badc7f9
746606nilotinib 200 MG Oral CapsuleSCD805cc504-60bb-7743-5ada-679eb3badc7f9
2002717nilotinib 50 MG Oral CapsuleSCD805cc504-60bb-7743-5ada-679eb3badc7f9
997653nilotinib (as nilotinib HCl) 150 MG Oral CapsuleSY805cc504-60bb-7743-5ada-679eb3badc7f9
746606nilotinib (as nilotinib HCl) 200 MG Oral CapsuleSY805cc504-60bb-7743-5ada-679eb3badc7f9
2002717nilotinib (as nilotinib hydrochloride) 50 MG Oral CapsuleSY805cc504-60bb-7743-5ada-679eb3badc7f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-055-0443598005504120 CAPSULE in 1 BOTTLE (43598-055-04) 120 capsule2025-11-19NoNoCurrent