DASATINIB

Product NDC
62332-686
11-digit product format
623320686
Labeler code
62332
Product ID
62332-686_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
70 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

Additional Listing Data#

Finished product
Yes
Brand name base
DASATINIB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DASATINIB70 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRBZ1571X5H
Rxcui643105, 643107, 643109, 799047, 1045402, 1045406

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b66e60ef-563e-ddb8-43b4-d625943af44bProduct name320251209
820d87d5-5779-4353-ae7e-33904df346a1Product name120241218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-686-60DASATINIB60 in 1 BOTTLETABLET, FILM COATED607

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799047dasatinib 100 MG Oral TabletPSNde3215a4-d098-4bc3-ad81-c7c9e34938727
1045402dasatinib 140 MG Oral TabletPSNde3215a4-d098-4bc3-ad81-c7c9e34938727
643105dasatinib 20 MG Oral TabletPSNde3215a4-d098-4bc3-ad81-c7c9e34938727
643107dasatinib 50 MG Oral TabletPSNde3215a4-d098-4bc3-ad81-c7c9e34938727
643109dasatinib 70 MG Oral TabletPSNde3215a4-d098-4bc3-ad81-c7c9e34938727
1045406dasatinib 80 MG Oral TabletPSNde3215a4-d098-4bc3-ad81-c7c9e34938727
799047dasatinib 100 MG Oral TabletSCDde3215a4-d098-4bc3-ad81-c7c9e34938727
1045402dasatinib 140 MG Oral TabletSCDde3215a4-d098-4bc3-ad81-c7c9e34938727
643105dasatinib 20 MG Oral TabletSCDde3215a4-d098-4bc3-ad81-c7c9e34938727
643107dasatinib 50 MG Oral TabletSCDde3215a4-d098-4bc3-ad81-c7c9e34938727
643109dasatinib 70 MG Oral TabletSCDde3215a4-d098-4bc3-ad81-c7c9e34938727
1045406dasatinib 80 MG Oral TabletSCDde3215a4-d098-4bc3-ad81-c7c9e34938727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-686-606233206866060 TABLET, FILM COATED in 1 BOTTLE (62332-686-60) 2025-11-11NoNoCurrent