Ultiva

In shortageOrange BookUNIISPLATC N01AH06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeN01AH06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6745791302
10 VIAL, GLASS in 1 CARTON (67457-913-02) / 5 mL in 1 VIAL, GLASS (67457-913-00)

Annotations

UNII (FDA Substance ID)

5V444H5WIC

REMIFENTANIL HYDROCHLORIDE

RxCUI 236540

Orange Book

N020630

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Remifentanil Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "5V444H5WIC",
    "rxcui": "236540",
    "inchikey": "WFBMIPUMYUHANP-UHFFFAOYSA-N",
    "display_name": "REMIFENTANIL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "8b4c8696-e23e-4c51-a4d2-babab5bd945a": {
      "match": "brand_token",
      "title": "ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "5",
      "published_date": "2026-01-01"
    }
  },
  "productid": "67457-913_4e4a5266-148c-4137-8fed-74766f8c1c7e",
  "productndc": "67457-913",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020630",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 12, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 12, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jul 12, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REMIFENTANIL HYDROCHLORIDE",
  "shortage_reason": "Remifentanil Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Ultiva",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020630",
  "marketing_category": "NDA",
  "nonproprietary_name": "Remifentanil Hydrochloride",
  "start_marketing_date": "20200415",
  "active_numerator_strength": "1"
}

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