dasatinib

Generic: dasatinib

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dasatinib 20 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-083
Product ID 70377-083_6718ab7c-7205-4927-4055-0ce76dfca7ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217217
Listing Expiration 2026-12-31
Marketing Start 2025-03-03

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 70377083
Hyphenated Format 70377-083

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 ANDA217217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (70377-083-11)
source: ndc

Packages (1)

70377-083-11 60 TABLET, FILM COATED in 1 BOTTLE (70377-083-11)

Ingredients (1)

dasatinib (20 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": "6718ab7c-7205-4927-4055-0ce76dfca7ac", "openfda": {"unii": ["RBZ1571X5H"], "rxcui": ["643105", "643107", "643109", "799047", "1045402", "1045406"], "spl_set_id": ["76e1833c-e105-5a3d-0f01-1330d8cc7ae1"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (70377-083-11)", "package_ndc": "70377-083-11", "marketing_start_date": "20250303"}], "brand_name": "Dasatinib", "product_id": "70377-083_6718ab7c-7205-4927-4055-0ce76dfca7ac", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "70377-083", "generic_name": "dasatinib", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dasatinib", "active_ingredients": [{"name": "DASATINIB", "strength": "20 mg/1"}], "application_number": "ANDA217217", "marketing_category": "ANDA", "marketing_start_date": "20250303", "listing_expiration_date": "20261231"}