PHYRAGO

Orange BookUNIISPLATC L01EA

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

Identification

ManufacturerCycle Pharmaceuticals Ltd

CountryUS (United States)

ATC codeL01EA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070915510
30 TABLET in 1 BOTTLE (70709-155-10)

Annotations

UNII (FDA Substance ID)

RBZ1571X5H

DASATINIB

RxCUI 475342

Orange Book

N216099

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": {
    "60976d1e-c415-417f-8168-4e07999a7281": {
      "match": "brand_token",
      "title": "PHYRAGO (DASATINIB) TABLET [CYCLE PHARMACEUTICALS LTD]",
      "spl_version": "3",
      "published_date": "2026-03-18"
    }
  },
  "productid": "70709-155_c853d4c8-8373-4603-bc62-41e53130c0aa",
  "productndc": "70709-155",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216099",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "70MG",
        "product_no": "003",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "140MG",
        "product_no": "006",
        "approval_date": "Dec 5, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DASATINIB",
  "proprietary_name": "PHYRAGO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216099",
  "marketing_category": "NDA",
  "nonproprietary_name": "dasatinib",
  "start_marketing_date": "20250922",
  "active_numerator_strength": "100"
}

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