Afinitor

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
0078062851
28 BLISTER PACK in 1 CARTON (0078-0628-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61)

Annotations

UNII (FDA Substance ID)

9HW64Q8G6G

EVEROLIMUS

RxCUI 141704

Orange Book

N203985

ABABAB

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": {
    "2150f73a-179b-4afc-b8ce-67c85cc72f04": {
      "match": "brand_token",
      "title": "AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "66",
      "published_date": "2026-02-16"
    }
  },
  "productid": "0078-0628_79d3253f-e1e3-428f-8dd4-4f2fe76faa15",
  "productndc": "0078-0628",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "203985",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EVEROLIMUS",
  "shortage_reason": "Everolimus Tablet",
  "shortage_status": "current",
  "proprietary_name": "Afinitor",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203985",
  "marketing_category": "NDA",
  "nonproprietary_name": "everolimus",
  "start_marketing_date": "20120829",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code L01EG02.

Access this data programmatically

Query Afinitor and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs