COMETRIQ

Orange BookSPL

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

Identification

ManufacturerExelixis, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4238801214
4 BLISTER PACK in 1 CARTON (42388-012-14) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N203756

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "1a0c3bea-c87b-4d25-bb44-5f0174da6b34": {
      "match": "brand_token",
      "title": "COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]",
      "spl_version": "16",
      "published_date": "2025-11-17"
    }
  },
  "productid": "42388-012_03fee098-20c7-4a04-81a7-06fb7d8b1470",
  "productndc": "42388-012",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203756",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Nov 29, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 80MG BASE",
        "product_no": "002",
        "approval_date": "Nov 29, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "COMETRIQ",
  "active_ingred_unit": null,
  "application_number": "NDA203756",
  "marketing_category": "NDA",
  "nonproprietary_name": "cabozantinib",
  "start_marketing_date": "20121129",
  "active_numerator_strength": null
}

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