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United States · US · US:50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864

ZELBORAF

Orange BookUNIISPLATC L01EC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5024209002
    1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
207SMY3FQT
VEMURAFENIB
RxCUI 1147220
Orange Book
N202429
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "207SMY3FQT",
    "rxcui": "1147220",
    "inchikey": "GPXBXXGIAQBQNI-UHFFFAOYSA-N",
    "display_name": "VEMURAFENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "38eea320-7e0c-485a-bc30-98c3c45e2763": {
      "match": "brand_token",
      "title": "ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]",
      "spl_version": "28",
      "published_date": "2025-12-10"
    }
  },
  "productid": "50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864",
  "productndc": "50242-090",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202429",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "240MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VEMURAFENIB",
  "proprietary_name": "ZELBORAF",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202429",
  "marketing_category": "NDA",
  "nonproprietary_name": "Vemurafenib",
  "start_marketing_date": "20110817",
  "active_numerator_strength": "240"
}

Related drugs

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