dasatinib

Generic: dasatinib

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dasatinib
Generic Name dasatinib
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dasatinib 80 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3816
Product ID 60505-3816_ec5a2f19-c89e-c4cd-c819-a22c585d18b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203180
Listing Expiration 2026-12-31
Marketing Start 2024-09-03

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 605053816
Hyphenated Format 60505-3816

Supplemental Identifiers

RxCUI
643105 643107 643109 799047 1045402 1045406
UPC
0360505381630 0360505363063
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 ANDA203180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)
source: ndc

Packages (1)

60505-3816-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)

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": "ec5a2f19-c89e-c4cd-c819-a22c585d18b4", "openfda": {"upc": ["0360505381630", "0360505363063"], "unii": ["RBZ1571X5H"], "rxcui": ["643105", "643107", "643109", "799047", "1045402", "1045406"], "spl_set_id": ["2ed87763-f018-abdb-c0ab-daa5e441b397"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)", "package_ndc": "60505-3816-3", "marketing_start_date": "20240903"}], "brand_name": "Dasatinib", "product_id": "60505-3816_ec5a2f19-c89e-c4cd-c819-a22c585d18b4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "60505-3816", "generic_name": "Dasatinib", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dasatinib", "active_ingredients": [{"name": "DASATINIB", "strength": "80 mg/1"}], "application_number": "ANDA203180", "marketing_category": "ANDA", "marketing_start_date": "20240903", "listing_expiration_date": "20261231"}