Remifentanil Hydrochloride

In shortageOrange BookUNIISPLATC N01AH06

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeN01AH06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332372510
10 VIAL, SINGLE-DOSE in 1 CARTON (63323-725-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-725-01)

Annotations

UNII (FDA Substance ID)

5V444H5WIC

REMIFENTANIL HYDROCHLORIDE

RxCUI 236540

Orange Book

A206223

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": {
    "5b8025d2-3424-477b-9cff-3990a98c2a65": {
      "match": "brand_token",
      "title": "REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "3",
      "published_date": "2025-03-10"
    }
  },
  "productid": "63323-725_2f27e51f-2b55-47ee-bd4a-001b71c60622",
  "productndc": "63323-725",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206223",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jan 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REMIFENTANIL HYDROCHLORIDE",
  "shortage_reason": "Remifentanil Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Remifentanil Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206223",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Remifentanil Hydrochloride",
  "start_marketing_date": "20180119",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N01AH06.

Access this data programmatically

Query Remifentanil Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs