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United States · US · US:51991-990_fade73fb-a367-4c53-83dd-1352c3ad807b

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
    5199199028
    4 BLISTER PACK in 1 CARTON (51991-990-28) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (51991-990-99)
  • ndc11
    5199199077
    28 TABLET, FOR SUSPENSION in 1 BOTTLE (51991-990-77)

Annotations

UNII (FDA Substance ID)
9HW64Q8G6G
EVEROLIMUS
RxCUI 141704
Orange Book
A217640
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": {
    "5cfca904-b75c-5a39-8cb9-b99bb421bceb": {
      "match": "brand_token",
      "title": "EVEROLIMUS TABLET [NORTHSTAR RXLLC]",
      "spl_version": "2",
      "published_date": "2026-04-22"
    }
  },
  "productid": "51991-990_fade73fb-a367-4c53-83dd-1352c3ad807b",
  "productndc": "51991-990",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "217640",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "002",
        "approval_date": "Jan 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jan 28, 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": "ANDA217640",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Everolimus",
  "start_marketing_date": "20250128",
  "active_numerator_strength": "2"
}

Related drugs

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