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United States · US · US:63323-810_a47a3a31-e293-49d5-b6bc-950303525a64

Fentanyl Citrate

In shortageOrange BookUNIISPLATC N02AB03

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN02AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332381020
    20 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00)

Annotations

UNII (FDA Substance ID)
MUN5LYG46H
FENTANYL CITRATE
RxCUI 142436
Orange Book
A212086
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": "63323-810_a47a3a31-e293-49d5-b6bc-950303525a64",
  "productndc": "63323-810",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212086",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.05MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 1, 2020"
      }
    ],
    "appl_type": "A"
  },
  "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/2mL",
  "application_number": "ANDA212086",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fentanyl Citrate",
  "start_marketing_date": "20210115",
  "active_numerator_strength": "100"
}

Related drugs

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