FDA.reportPublic FDA data

Tasigna

Product NDC
0078-0526
11-digit product format
000780526
Labeler code
0078
Product ID
0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA022068
Marketing category
NDA
Marketing start
2007-10-29
Substance
NILOTINIB HYDROCHLORIDE MONOHYDRATE
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
Tasigna
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NILOTINIB HYDROCHLORIDE MONOHYDRATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5JHU0N1R6K
Rxcui746606, 746609, 997653, 1002300, 2002717, 2002719

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
0078-0526-51Tasigna28 in 1 BLISTER PACKCAPSULE2842
0078-0526-87Tasigna4 in 1 CARTONCAPSULE442
0078-0526-87Tasigna28 in 1 BLISTER PACKCAPSULE2842

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0526-51EA - Each0078-0526443558e3-f1b6-4b66-bb79-5683412f735112012-07-24
0078-0526-87EA - Each0078-0526acc0189c-c833-4249-af50-c002aeae4d6d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NILOTINIBACTIVE INGREDIENTF41401512XTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
NILOTINIBACTIVE MOIETYF41401512XTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
GELATININACTIVE INGREDIENT2G86QN327LTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0526TASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]41Current NDC, Legacy NDC, 3 package rows20250223_6093952a-5248-45cb-ad17-33716a411146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997653nilotinib 150 MG Oral CapsulePSN6093952a-5248-45cb-ad17-33716a41114642
746606nilotinib 200 MG Oral CapsulePSN6093952a-5248-45cb-ad17-33716a41114642
2002717nilotinib 50 MG Oral CapsulePSN6093952a-5248-45cb-ad17-33716a41114642
1002300Tasigna 150 MG Oral CapsulePSN6093952a-5248-45cb-ad17-33716a41114642
746609Tasigna 200 MG Oral CapsulePSN6093952a-5248-45cb-ad17-33716a41114642
2002719Tasigna 50 MG Oral CapsulePSN6093952a-5248-45cb-ad17-33716a41114642
1002300nilotinib 150 MG Oral Capsule [Tasigna]SBD6093952a-5248-45cb-ad17-33716a41114642
746609nilotinib 200 MG Oral Capsule [Tasigna]SBD6093952a-5248-45cb-ad17-33716a41114642
2002719nilotinib 50 MG Oral Capsule [Tasigna]SBD6093952a-5248-45cb-ad17-33716a41114642
997653nilotinib 150 MG Oral CapsuleSCD6093952a-5248-45cb-ad17-33716a41114642
746606nilotinib 200 MG Oral CapsuleSCD6093952a-5248-45cb-ad17-33716a41114642
2002717nilotinib 50 MG Oral CapsuleSCD6093952a-5248-45cb-ad17-33716a41114642
997653nilotinib (as nilotinib HCl) 150 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
746606nilotinib (as nilotinib HCl) 200 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
2002717nilotinib (as nilotinib hydrochloride) 50 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
1002300Tasigna (as nilotinib HCl) 150 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
746609Tasigna (as nilotinib HCl) 200 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
1002300Tasigna 150 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
746609Tasigna 200 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642
2002719Tasigna 50 MG Oral CapsuleSY6093952a-5248-45cb-ad17-33716a41114642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0526-510007805265128 CAPSULE in 1 BLISTER PACK (0078-0526-51) 28 capsule2007-10-290000-00-00NoNoCurrent
0078-0526-87000780526874 BLISTER PACK in 1 CARTON (0078-0526-87) / 28 CAPSULE in 1 BLISTER PACK4 blister pack2007-10-290000-00-00NoNoCurrent