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United States · US · US:51991-985_e7f5ef4d-6763-4908-9b64-c2a2f600b2c8

Everolimus

In shortageOrange BookUNIISPLATC L01EG02

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeL01EG02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5199198506
    60 TABLET in 1 BOTTLE (51991-985-06)
  • ndc11
    5199198599
    60 BLISTER PACK in 1 CARTON (51991-985-99) / 10 TABLET in 1 BLISTER PACK (51991-985-60)

Annotations

UNII (FDA Substance ID)
9HW64Q8G6G
EVEROLIMUS
RxCUI 141704
Orange Book
A205432
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": "51991-985_e7f5ef4d-6763-4908-9b64-c2a2f600b2c8",
  "productndc": "51991-985",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205432",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "May 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "May 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "003",
        "approval_date": "May 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "004",
        "approval_date": "Sep 3, 2025"
      }
    ],
    "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": "ANDA205432",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Everolimus tablets",
  "start_marketing_date": "20251030",
  "active_numerator_strength": "1"
}

Related drugs

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