nilotinib

Product NDC
73190-033
11-digit product format
731900033
Labeler code
73190
Product ID
73190-033_4c0bc87a-7a6c-af1e-e063-6394a90a5495
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA218544
Marketing category
ANDA
Marketing start
2026-03-02
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
F41401512XNILOTINIB641571-10-0NILOTINIB

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73190-033-117319000331128 CAPSULE in 1 BLISTER PACK (73190-033-11) 28 capsule2026-03-02NoNoHistorical
73190-033-12731900033124 BLISTER PACK in 1 CARTON (73190-033-12) / 28 CAPSULE in 1 BLISTER PACK4 blister pack2026-03-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
nilotinibAvKARE2026-03-02HUMAN PRESCRIPTION DRUG LABEL1