ROMVIMZA

Orange BookUNIISPLATC L01EX

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

Identification

ManufacturerDeciphera Pharmaceuticals, LLC

CountryUS (United States)

ATC codeL01EX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7320730240
1 CARTON in 1 CARTON (73207-302-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK
ndc11
7320730241
1 CARTON in 1 CARTON (73207-302-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

PX9FTM69BF

VIMSELTINIB

Orange Book

N219304

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "PX9FTM69BF",
    "rxcui": null,
    "inchikey": "TVGAHWWPABTBCX-UHFFFAOYSA-N",
    "display_name": "VIMSELTINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f73c7a62-9601-4df0-810f-100f515d79ea": {
      "match": "brand_token",
      "title": "ROMVIMZA (VIMSELTINIB) CAPSULE [DECIPHERA PHARMACEUTICALS, LLC]",
      "spl_version": "2",
      "published_date": "2025-12-23"
    }
  },
  "productid": "73207-302_6362e653-0e8c-4b90-b4e9-89647080e9d9",
  "productndc": "73207-302",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219304",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "14MG",
        "product_no": "001",
        "approval_date": "Feb 14, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Feb 14, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Feb 14, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VIMSELTINIB",
  "proprietary_name": "ROMVIMZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219304",
  "marketing_category": "NDA",
  "nonproprietary_name": "Vimseltinib",
  "start_marketing_date": "20250214",
  "active_numerator_strength": "14"
}

Related drugs

Other records sharing ATC code L01EX.

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