Dasatinib

Product NDC
0480-5104
11-digit product format
004805104
Labeler code
0480
Product ID
0480-5104_4f8ca317-4225-4d8f-b028-836e1dd07fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dasatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA211094
Marketing category
ANDA
Marketing start
2025-09-18
Substance
DASATINIB
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
RBZ1571X5HDASATINIB863127-77-9DASATINIB

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-5104-560048051045630 TABLET, FILM COATED in 1 BOTTLE (0480-5104-56) 2025-09-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DasatinibAvKARE2025-11-18HUMAN PRESCRIPTION DRUG LABEL1
DasatinibTeva Pharmaceuticals, Inc.2024-08-31HUMAN PRESCRIPTION DRUG LABEL4