FDA.reportPublic FDA data

nilotinib

Product NDC
13668-711
11-digit product format
136680711
Labeler code
13668
Product ID
13668-711_8e83f910-85f0-4646-b330-179f02acddf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA218532
Marketing category
ANDA
Marketing start
2025-12-16
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
nilotinib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NILOTINIB HYDROCHLORIDE MONOHYDRATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5JHU0N1R6K
Rxcui746606, 997653

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
13668-711-57nilotinib4 in 1 CARTONCAPSULE45
13668-711-57nilotinib28 in 1 BLISTER PACKCAPSULE285
13668-711-91nilotinib1 in 1 CARTONCAPSULE15
13668-711-91nilotinib28 in 1 BLISTER PACKCAPSULE285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-711-57EA - Each13668-711b279b8c1-159f-4777-9808-4ae5aee9f67a12026-01-08
13668-711-91EA - Each13668-711dfb70d29-f942-4970-879f-bad23e5fd2ca12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997653nilotinib 150 MG Oral CapsulePSNb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
746606nilotinib 200 MG Oral CapsulePSNb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
997653nilotinib 150 MG Oral CapsuleSCDb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
746606nilotinib 200 MG Oral CapsuleSCDb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
997653nilotinib (as nilotinib HCl) 150 MG Oral CapsuleSYb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
746606nilotinib (as nilotinib HCl) 200 MG Oral CapsuleSYb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-711-57136680711574 BLISTER PACK in 1 CARTON (13668-711-57) / 28 CAPSULE in 1 BLISTER PACK4 blister pack2025-12-16NoNoHistorical
13668-711-91136680711911 BLISTER PACK in 1 CARTON (13668-711-91) / 28 CAPSULE in 1 BLISTER PACK1 blister pack2025-12-16NoNoHistorical