dasatinib

Generic: dasatinib

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dasatinib
Generic Name dasatinib
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dasatinib 80 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3523
Product ID 0480-3523_4f8ca317-4225-4d8f-b028-836e1dd07fe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211094
Listing Expiration 2026-12-31
Marketing Start 2025-09-18

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 04803523
Hyphenated Format 0480-3523

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 ANDA211094 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0480-3523-56)
source: ndc

Packages (1)

0480-3523-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-3523-56)

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": "4f8ca317-4225-4d8f-b028-836e1dd07fe1", "openfda": {"unii": ["RBZ1571X5H"], "rxcui": ["643105", "643107", "643109", "799047", "1045402", "1045406"], "spl_set_id": ["3000fd91-1b09-4d72-8522-1ca5e35ed956"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3523-56)", "package_ndc": "0480-3523-56", "marketing_start_date": "20250918"}], "brand_name": "Dasatinib", "product_id": "0480-3523_4f8ca317-4225-4d8f-b028-836e1dd07fe1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0480-3523", "generic_name": "Dasatinib", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dasatinib", "active_ingredients": [{"name": "DASATINIB", "strength": "80 mg/1"}], "application_number": "ANDA211094", "marketing_category": "ANDA", "marketing_start_date": "20250918", "listing_expiration_date": "20261231"}