Everolimus

In shortageOrange BookUNIISPLATC L01EG02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL01EG02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054047021
60 TABLET in 1 BOTTLE (0054-0470-21)

Annotations

UNII (FDA Substance ID)

9HW64Q8G6G

EVEROLIMUS

RxCUI 141704

Orange Book

A206133

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": {
    "5cfca904-b75c-5a39-8cb9-b99bb421bceb": {
      "match": "brand_token",
      "title": "EVEROLIMUS TABLET [NORTHSTAR RXLLC]",
      "spl_version": "2",
      "published_date": "2026-04-22"
    }
  },
  "productid": "0054-0470_496ea375-42a1-422e-88ad-0b1c6df703aa",
  "productndc": "0054-0470",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206133",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Apr 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "003",
        "approval_date": "Apr 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "004",
        "approval_date": "Nov 18, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EVEROLIMUS",
  "shortage_reason": "Everolimus Tablet",
  "shortage_status": "current",
  "proprietary_name": "Everolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206133",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Everolimus",
  "start_marketing_date": "20200310",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code L01EG02.

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