dasatinib

Generic: dasatinib

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dasatinib
Generic Name dasatinib
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dasatinib 80 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-545
Product ID 59651-545_58ce42c6-10bd-4bb4-bf89-eae8ed82c339
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216547
Listing Expiration 2026-12-31
Marketing Start 2025-04-22

Pharmacologic Class

Classes
cytochrome p450 3a4 inhibitors [moa] kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651545
Hyphenated Format 59651-545

Supplemental Identifiers

RxCUI
643105 643107 643109 799047 1045402 1045406
UNII
RBZ1571X5H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dasatinib (source: ndc)
Generic Name dasatinib (source: ndc)
Application Number ANDA216547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59651-545-15) / 15 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (59651-545-30)
source: ndc

Packages (2)

59651-545-15 1 BLISTER PACK in 1 CARTON (59651-545-15) / 15 TABLET in 1 BLISTER PACK 59651-545-30 30 TABLET in 1 BOTTLE (59651-545-30)

Ingredients (1)

dasatinib (80 mg/1)

Linked Drug Pages (1)

DASATINIB ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "58ce42c6-10bd-4bb4-bf89-eae8ed82c339", "openfda": {"unii": ["RBZ1571X5H"], "rxcui": ["643105", "643107", "643109", "799047", "1045402", "1045406"], "spl_set_id": ["58ce42c6-10bd-4bb4-bf89-eae8ed82c339"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-545-15)  / 15 TABLET in 1 BLISTER PACK", "package_ndc": "59651-545-15", "marketing_start_date": "20250422"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-545-30)", "package_ndc": "59651-545-30", "marketing_start_date": "20250422"}], "brand_name": "DASATINIB", "product_id": "59651-545_58ce42c6-10bd-4bb4-bf89-eae8ed82c339", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "59651-545", "generic_name": "DASATINIB", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DASATINIB", "active_ingredients": [{"name": "DASATINIB", "strength": "80 mg/1"}], "application_number": "ANDA216547", "marketing_category": "ANDA", "marketing_start_date": "20250422", "listing_expiration_date": "20261231"}