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United States · US · US:65219-447_30488a7e-ea9e-4a27-95a9-a07149c50282

Etomidate

In shortageOrange BookUNIISPLATC N01AX07

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN01AX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521944720
    10 VIAL, SINGLE-DOSE in 1 CARTON (65219-447-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-447-02)

Annotations

UNII (FDA Substance ID)
Z22628B598
ETOMIDATE
RxCUI 4177
Orange Book
A215028
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Etomidate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "Z22628B598",
    "rxcui": "4177",
    "inchikey": "NPUKDXXFDDZOKR-LLVKDONJSA-N",
    "display_name": "ETOMIDATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9c2d0014-9e74-40b2-b452-255016c81cc1": {
      "match": "brand_token",
      "title": "ETOMIDATE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]",
      "spl_version": "4",
      "published_date": "2026-02-06"
    }
  },
  "productid": "65219-447_30488a7e-ea9e-4a27-95a9-a07149c50282",
  "productndc": "65219-447",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215028",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Dec 18, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETOMIDATE",
  "shortage_reason": "Etomidate Injection",
  "shortage_status": "current",
  "proprietary_name": "Etomidate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215028",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etomidate",
  "start_marketing_date": "20210801",
  "active_numerator_strength": "2"
}

Related drugs

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