dasatinib

Generic: dasatinib

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dasatinib
Generic Name dasatinib
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dasatinib 80 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-687
Product ID 46708-687_645fcf26-1b2f-40c5-881b-8effe02defbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216261
Listing Expiration 2026-12-31
Marketing Start 2025-11-11

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 46708687
Hyphenated Format 46708-687

Supplemental Identifiers

RxCUI
643105 643107 643109 799047 1045402 1045406
UPC
0346708684600
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 ANDA216261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-687-30)
source: ndc

Packages (1)

46708-687-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-687-30)

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": "645fcf26-1b2f-40c5-881b-8effe02defbd", "openfda": {"upc": ["0346708684600"], "unii": ["RBZ1571X5H"], "rxcui": ["643105", "643107", "643109", "799047", "1045402", "1045406"], "spl_set_id": ["645fcf26-1b2f-40c5-881b-8effe02defbd"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-687-30)", "package_ndc": "46708-687-30", "marketing_start_date": "20251111"}], "brand_name": "DASATINIB", "product_id": "46708-687_645fcf26-1b2f-40c5-881b-8effe02defbd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "46708-687", "generic_name": "DASATINIB", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DASATINIB", "active_ingredients": [{"name": "DASATINIB", "strength": "80 mg/1"}], "application_number": "ANDA216261", "marketing_category": "ANDA", "marketing_start_date": "20251111", "listing_expiration_date": "20261231"}