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United States · US · US:50242-140_d8b343ee-5767-4934-ad68-5164d4de5228

ERIVEDGE

Orange BookUNIISPLATC L01XJ01

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

Identification

ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01XJ01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5024214001
    1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC
  • ndc11
    5024214086
    1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
25X868M3DS
VISMODEGIB
RxCUI 1242987
Orange Book
N203388
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "25X868M3DS",
    "rxcui": "1242987",
    "inchikey": "BPQMGSKTAYIVFO-UHFFFAOYSA-N",
    "display_name": "VISMODEGIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "eb368bb6-80e3-4df9-8a85-91df0a2ada6a": {
      "match": "brand_token",
      "title": "ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.]",
      "spl_version": "15",
      "published_date": "2024-12-10"
    }
  },
  "productid": "50242-140_d8b343ee-5767-4934-ad68-5164d4de5228",
  "productndc": "50242-140",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203388",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VISMODEGIB",
  "proprietary_name": "ERIVEDGE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203388",
  "marketing_category": "NDA",
  "nonproprietary_name": "vismodegib",
  "start_marketing_date": "20120130",
  "active_numerator_strength": "150"
}

Related drugs

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