Ayvakit

Orange BookUNIISPLATC L01EX18

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

Identification

ManufacturerBlueprint Medicines Corporation

CountryUS (United States)

ATC codeL01EX18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7206413030
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-130-30)

Annotations

UNII (FDA Substance ID)

513P80B4YJ

AVAPRITINIB

RxCUI 2272107

Orange Book

N212608

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "513P80B4YJ",
    "rxcui": "2272107",
    "inchikey": "DWYRIWUZIJHQKQ-SANMLTNESA-N",
    "display_name": "AVAPRITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "645c887c-8cd4-4623-8da9-ac223d71a8b9": {
      "match": "brand_token",
      "title": "AYVAKIT (AVAPRITINIB) TABLET, FILM COATED [BLUEPRINT MEDICINES CORPORATION]",
      "spl_version": "13",
      "published_date": "2025-07-14"
    }
  },
  "productid": "72064-130_5cf92ebf-46ff-4b14-becc-848ef1a79282",
  "productndc": "72064-130",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212608",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 9, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jan 9, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Jan 9, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "004",
        "approval_date": "Jun 16, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Jun 16, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AVAPRITINIB",
  "proprietary_name": "Ayvakit",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212608",
  "marketing_category": "NDA",
  "nonproprietary_name": "avapritinib",
  "start_marketing_date": "20200109",
  "active_numerator_strength": "300"
}

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