DASATINIB

Orange BookUNIISPLATC L01EA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeL01EA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965154415
1 BLISTER PACK in 1 CARTON (59651-544-15) / 15 TABLET in 1 BLISTER PACK
ndc11
5965154460
60 TABLET in 1 BOTTLE (59651-544-60)

Annotations

UNII (FDA Substance ID)

RBZ1571X5H

DASATINIB

RxCUI 475342

Orange Book

A216547

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RBZ1571X5H",
    "rxcui": "475342",
    "inchikey": "XHXFZZNHDVTMLI-UHFFFAOYSA-N",
    "display_name": "DASATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f9b79d54-9bee-4c93-9c87-f3e65d91f146": {
      "match": "brand_token",
      "title": "DASATINIB TABLET, FILM COATED [NORTHSTAR RXLLC]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "59651-544_58ce42c6-10bd-4bb4-bf89-eae8ed82c339",
  "productndc": "59651-544",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216547",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "003",
        "approval_date": "Apr 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Apr 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Apr 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "006",
        "approval_date": "Apr 22, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DASATINIB",
  "proprietary_name": "DASATINIB",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216547",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DASATINIB",
  "start_marketing_date": "20250422",
  "active_numerator_strength": "70"
}

Related drugs

Other records sharing ATC code L01EA.

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