Dasatinib

Product NDC
0480-3523
11-digit product format
004803523
Labeler code
0480
Product ID
0480-3523_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
80 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3523-56Dasatinib30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3523-56EA - Each0480-3523dbe4918d-9012-4be7-bae0-a1d6917e5d8412025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799047dasatinib 100 MG Oral TabletPSN3000fd91-1b09-4d72-8522-1ca5e35ed9564
1045402dasatinib 140 MG Oral TabletPSN3000fd91-1b09-4d72-8522-1ca5e35ed9564
643105dasatinib 20 MG Oral TabletPSN3000fd91-1b09-4d72-8522-1ca5e35ed9564
643107dasatinib 50 MG Oral TabletPSN3000fd91-1b09-4d72-8522-1ca5e35ed9564
643109dasatinib 70 MG Oral TabletPSN3000fd91-1b09-4d72-8522-1ca5e35ed9564
1045406dasatinib 80 MG Oral TabletPSN3000fd91-1b09-4d72-8522-1ca5e35ed9564
799047dasatinib 100 MG Oral TabletSCD3000fd91-1b09-4d72-8522-1ca5e35ed9564
1045402dasatinib 140 MG Oral TabletSCD3000fd91-1b09-4d72-8522-1ca5e35ed9564
643105dasatinib 20 MG Oral TabletSCD3000fd91-1b09-4d72-8522-1ca5e35ed9564
643107dasatinib 50 MG Oral TabletSCD3000fd91-1b09-4d72-8522-1ca5e35ed9564
643109dasatinib 70 MG Oral TabletSCD3000fd91-1b09-4d72-8522-1ca5e35ed9564
1045406dasatinib 80 MG Oral TabletSCD3000fd91-1b09-4d72-8522-1ca5e35ed9564
799047dasatinib 100 MG Oral TabletPSN43e078b9-4e0b-edeb-e063-6294a90a75861
1045402dasatinib 140 MG Oral TabletPSN43e078b9-4e0b-edeb-e063-6294a90a75861
643105dasatinib 20 MG Oral TabletPSN43e078b9-4e0b-edeb-e063-6294a90a75861
643107dasatinib 50 MG Oral TabletPSN43e078b9-4e0b-edeb-e063-6294a90a75861
643109dasatinib 70 MG Oral TabletPSN43e078b9-4e0b-edeb-e063-6294a90a75861
1045406dasatinib 80 MG Oral TabletPSN43e078b9-4e0b-edeb-e063-6294a90a75861
799047dasatinib 100 MG Oral TabletSCD43e078b9-4e0b-edeb-e063-6294a90a75861
1045402dasatinib 140 MG Oral TabletSCD43e078b9-4e0b-edeb-e063-6294a90a75861
643105dasatinib 20 MG Oral TabletSCD43e078b9-4e0b-edeb-e063-6294a90a75861
643107dasatinib 50 MG Oral TabletSCD43e078b9-4e0b-edeb-e063-6294a90a75861
643109dasatinib 70 MG Oral TabletSCD43e078b9-4e0b-edeb-e063-6294a90a75861
1045406dasatinib 80 MG Oral TabletSCD43e078b9-4e0b-edeb-e063-6294a90a75861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-3523-560048035235630 TABLET, FILM COATED in 1 BOTTLE (0480-3523-56) 2025-09-18NoNoCurrent