Zortress

In shortageOrange BookUNIISPLATC L01EG02

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeL01EG02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078041720
60 BLISTER PACK in 1 BOX (0078-0417-20) / 1 TABLET in 1 BLISTER PACK (0078-0417-61)

Annotations

UNII (FDA Substance ID)

9HW64Q8G6G

EVEROLIMUS

RxCUI 141704

Orange Book

N021560

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Everolimus Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "9HW64Q8G6G",
    "rxcui": "141704",
    "inchikey": "HKVAMNSJSFKALM-GKUWKFKPSA-N",
    "display_name": "EVEROLIMUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e082a024-7850-400b-a5c2-2a140612562a": {
      "match": "brand_token",
      "title": "ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "29",
      "published_date": "2026-02-16"
    }
  },
  "productid": "0078-0417_5b9ba6f0-1e1d-4b9c-9122-ad856284d7ca",
  "productndc": "0078-0417",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021560",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Apr 20, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Apr 20, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "003",
        "approval_date": "Apr 20, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "004",
        "approval_date": "Aug 10, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EVEROLIMUS",
  "shortage_reason": "Everolimus Tablet",
  "shortage_status": "current",
  "proprietary_name": "Zortress",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021560",
  "marketing_category": "NDA",
  "nonproprietary_name": "everolimus",
  "start_marketing_date": "20100422",
  "active_numerator_strength": ".25"
}

Related drugs

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