VANFLYTA

Orange BookUNIISPLATC L01EX11

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

Identification

ManufacturerDaiichi Sankyo Inc.

CountryUS (United States)

ATC codeL01EX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6559751104
1 BOTTLE in 1 CARTON (65597-511-04) / 14 TABLET, FILM COATED in 1 BOTTLE
ndc11
6559751128
1 BOTTLE in 1 CARTON (65597-511-28) / 28 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

WK7Q6ZIZ10

QUIZARTINIB DIHYDROCHLORIDE

Orange Book

N216993

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WK7Q6ZIZ10",
    "rxcui": null,
    "inchikey": "DHYPGRVMIOATAE-UHFFFAOYSA-N",
    "display_name": "QUIZARTINIB DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "29cdbcfe-497d-4e78-bb7b-2d4acafe8e86": {
      "match": "brand_token",
      "title": "VANFLYTA (QUIZARTINIB) TABLET, FILM COATED [DAIICHI SANKYO INC.]",
      "spl_version": "11",
      "published_date": "2026-04-22"
    }
  },
  "productid": "65597-511_ee05ebbe-cace-4b2f-bb89-c26687c1eeaf",
  "productndc": "65597-511",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216993",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 17.7MG BASE",
        "product_no": "001",
        "approval_date": "Jul 20, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 26.5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 20, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUIZARTINIB DIHYDROCHLORIDE",
  "proprietary_name": "VANFLYTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216993",
  "marketing_category": "NDA",
  "nonproprietary_name": "QUIZARTINIB",
  "start_marketing_date": "20230720",
  "active_numerator_strength": "26.5"
}

Related drugs

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