REMIFENTANIL HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N01AH06

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN01AH06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143939110
10 VIAL in 1 CARTON (0143-9391-10) / 3 mL in 1 VIAL (0143-9391-01)

Annotations

UNII (FDA Substance ID)

5V444H5WIC

REMIFENTANIL HYDROCHLORIDE

RxCUI 236540

Orange Book

A210594

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": "0143-9391_5c5e498b-d829-4f78-bcca-466631014767",
  "productndc": "0143-9391",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210594",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 13, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Oct 13, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Oct 13, 2020"
      }
    ],
    "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": "ANDA210594",
  "marketing_category": "ANDA",
  "nonproprietary_name": "REMIFENTANIL HYDROCHLORIDE",
  "start_marketing_date": "20210515",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N01AH06.

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