FDA.reportPublic FDA data

Dasatinib

Product NDC
68001-663
11-digit product format
680010663
Labeler code
68001
Product ID
68001-663_4c4a021d-a810-26d0-e063-6294a90abd2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dasatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA217217
Marketing category
ANDA
Marketing start
2025-12-01
Substance
DASATINIB
Active strength
80 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dasatinib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DASATINIB80 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-663-04Dasatinib30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-663-04EA - Each68001-6634cdc1f40-1309-4f85-967f-a8a84b2524ba12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799047dasatinib 100 MG Oral TabletPSN02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
1045402dasatinib 140 MG Oral TabletPSN02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
643105dasatinib 20 MG Oral TabletPSN02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
643107dasatinib 50 MG Oral TabletPSN02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
643109dasatinib 70 MG Oral TabletPSN02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
1045406dasatinib 80 MG Oral TabletPSN02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
799047dasatinib 100 MG Oral TabletSCD02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
1045402dasatinib 140 MG Oral TabletSCD02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
643105dasatinib 20 MG Oral TabletSCD02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
643107dasatinib 50 MG Oral TabletSCD02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
643109dasatinib 70 MG Oral TabletSCD02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42
1045406dasatinib 80 MG Oral TabletSCD02b04c6f-4ea5-4fcb-bf6d-2631d5ab31e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-663-046800106630430 TABLET, FILM COATED in 1 BOTTLE (68001-663-04) 2025-12-01NoNoHistorical