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United States · US · US:0404-9811_53c329b0-76c1-42c8-96d3-f01088ce5bd8

Amidate

In shortageOrange BookUNIISPLATC N01AX07

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

Identification

ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeN01AX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0404981110
    1 VIAL, SINGLE-DOSE in 1 BAG (0404-9811-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
Z22628B598
ETOMIDATE
RxCUI 4177
Orange Book
N018227
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": {
    "b7ed5bf8-ba75-44dc-8f81-96b4ad5766be": {
      "match": "brand_token",
      "title": "AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "27",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0404-9811_53c329b0-76c1-42c8-96d3-f01088ce5bd8",
  "productndc": "0404-9811",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018227",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Sep 7, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETOMIDATE",
  "shortage_reason": "Etomidate Injection",
  "shortage_status": "current",
  "proprietary_name": "Amidate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018227",
  "marketing_category": "NDA",
  "nonproprietary_name": "Etomidate",
  "start_marketing_date": "20220106",
  "active_numerator_strength": "2"
}

Related drugs

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