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United States · US · US:0409-9093_5c5d5060-ba53-4e88-b390-f03217605d11

FENTANYL CITRATE

In shortageOrange BookUNIISPLATC N02AB03

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeN02AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409909311
    10 AMPULE in 1 CELLO PACK (0409-9093-11) / 2 mL in 1 AMPULE (0409-9093-09)

Annotations

UNII (FDA Substance ID)
MUN5LYG46H
FENTANYL CITRATE
RxCUI 142436
Orange Book
N019115
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fentanyl Citrate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "MUN5LYG46H",
    "rxcui": "142436",
    "inchikey": "IVLVTNPOHDFFCJ-UHFFFAOYSA-N",
    "display_name": "FENTANYL CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "e15a7e9b-8025-49dd-9a6d-bafcccf1959f": {
      "match": "brand_token",
      "title": "FENTANYL TRANSDERMAL PATCH, EXTENDED RELEASE [SPECGX LLC]",
      "spl_version": "58",
      "published_date": "2026-05-06"
    }
  },
  "productid": "0409-9093_5c5d5060-ba53-4e88-b390-f03217605d11",
  "productndc": "0409-9093",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019115",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.05MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jan 12, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENTANYL CITRATE",
  "shortage_reason": "Fentanyl Citrate Injection",
  "shortage_status": "current",
  "proprietary_name": "FENTANYL CITRATE",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA019115",
  "marketing_category": "NDA",
  "nonproprietary_name": "fentanyl citrate",
  "start_marketing_date": "20161206",
  "active_numerator_strength": "50"
}

Related drugs

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