Dasatinib

Product NDC
70377-088
11-digit product format
703770088
Labeler code
70377
Product ID
70377-088_6718ab7c-7205-4927-4055-0ce76dfca7ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dasatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA217217
Marketing category
ANDA
Marketing start
2025-03-03
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DASATINIB140 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
70377-088-11Dasatinib30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-088-11EA - Each70377-088f7addf89-b69d-416d-bd7b-05a85b9b3ead12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-088DASATINIB (DASATINIB) TABLET, FILM COATED DASATINIB (DASATINIB) TABLET, FILM COATED [BIOCON PHARMA INC.]7Current NDC, 1 package rows20250306_76e1833c-e105-5a3d-0f01-1330d8cc7ae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799047dasatinib 100 MG Oral TabletPSN76e1833c-e105-5a3d-0f01-1330d8cc7ae17
1045402dasatinib 140 MG Oral TabletPSN76e1833c-e105-5a3d-0f01-1330d8cc7ae17
643105dasatinib 20 MG Oral TabletPSN76e1833c-e105-5a3d-0f01-1330d8cc7ae17
643107dasatinib 50 MG Oral TabletPSN76e1833c-e105-5a3d-0f01-1330d8cc7ae17
643109dasatinib 70 MG Oral TabletPSN76e1833c-e105-5a3d-0f01-1330d8cc7ae17
1045406dasatinib 80 MG Oral TabletPSN76e1833c-e105-5a3d-0f01-1330d8cc7ae17
799047dasatinib 100 MG Oral TabletSCD76e1833c-e105-5a3d-0f01-1330d8cc7ae17
1045402dasatinib 140 MG Oral TabletSCD76e1833c-e105-5a3d-0f01-1330d8cc7ae17
643105dasatinib 20 MG Oral TabletSCD76e1833c-e105-5a3d-0f01-1330d8cc7ae17
643107dasatinib 50 MG Oral TabletSCD76e1833c-e105-5a3d-0f01-1330d8cc7ae17
643109dasatinib 70 MG Oral TabletSCD76e1833c-e105-5a3d-0f01-1330d8cc7ae17
1045406dasatinib 80 MG Oral TabletSCD76e1833c-e105-5a3d-0f01-1330d8cc7ae17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70377-088-117037700881130 TABLET, FILM COATED in 1 BOTTLE (70377-088-11) 2025-03-03NoNoHistorical