Itovebi

Orange BookUNIISPLATC L01EM

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

Identification

ManufacturerGenentech, Inc.

CountryUS (United States)

ATC codeL01EM

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5024208408
1 BOTTLE in 1 CARTON (50242-084-08) / 28 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

L4C1UY2NYH

INAVOLISIB

Orange Book

N219249

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L4C1UY2NYH",
    "rxcui": null,
    "inchikey": "SGEUNORSOZVTOL-CABZTGNLSA-N",
    "display_name": "INAVOLISIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5de59f5b-e5db-410f-b692-658686ef4107": {
      "match": "brand_token",
      "title": "ITOVEBI (INAVOLISIB) TABLET, FILM COATED [GENENTECH, INC.]",
      "spl_version": "10",
      "published_date": "2026-04-28"
    }
  },
  "productid": "50242-084_dd6ab36d-21fa-4513-a9d1-0867ca4420e8",
  "productndc": "50242-084",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219249",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3MG",
        "product_no": "001",
        "approval_date": "Oct 10, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "9MG",
        "product_no": "002",
        "approval_date": "Oct 10, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INAVOLISIB",
  "proprietary_name": "Itovebi",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219249",
  "marketing_category": "NDA",
  "nonproprietary_name": "Inavolisib",
  "start_marketing_date": "20241014",
  "active_numerator_strength": "3"
}

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