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United States · US · US:70377-091_38b19b37-504e-24ed-7dbc-8b9f9e3fda0a

Everolimus

In shortageOrange BookUNIISPLATC L01EG02

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

Identification

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

Packs · 2

  • ndc11
    7037709111
    28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-091-11)
  • ndc11
    7037709123
    4 BLISTER PACK in 1 CARTON (70377-091-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
9HW64Q8G6G
EVEROLIMUS
RxCUI 141704
Orange Book
A217216
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": "70377-091_38b19b37-504e-24ed-7dbc-8b9f9e3fda0a",
  "productndc": "70377-091",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "217216",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 9, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "002",
        "approval_date": "Jan 9, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jan 9, 2026"
      }
    ],
    "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": "ANDA217216",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Everolimus",
  "start_marketing_date": "20260114",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code L01EG02.

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