DASATINIB

Product NDC
46708-689
11-digit product format
467080689
Labeler code
46708
Product ID
46708-689_645fcf26-1b2f-40c5-881b-8effe02defbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DASATINIB
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA216261
Marketing category
ANDA
Marketing start
2025-11-11
Substance
DASATINIB
Active strength
140 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
46708-689-304670806893030 TABLET, FILM COATED in 1 BOTTLE (46708-689-30) 2025-11-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DASATINIBAlembic Pharmaceuticals Limited2025-11-12Human Prescription Drug Label1