DASATINIB

Product NDC
62332-685
11-digit product format
623320685
Labeler code
62332
Product ID
62332-685_e31caab8-d233-412a-abc7-5416958c0264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DASATINIB
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216261
Marketing category
ANDA
Marketing start
2025-11-11
Substance
DASATINIB
Active strength
50 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
62332-685-606233206856060 TABLET, FILM COATED in 1 BOTTLE (62332-685-60) 2025-11-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DASATINIBAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2025-11-11Human Prescription Drug Label7