Fentanyl system

In shortageOrange BookUNIISPLATC N02AB03

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

Identification

ManufacturerALVOGEN

CountryUS (United States)

ATC codeN02AB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4778142447
5 POUCH in 1 CARTON (47781-424-47) / 1 PATCH in 1 POUCH (47781-424-11)

Annotations

UNII (FDA Substance ID)

UF599785JZ

FENTANYL

RxCUI 4337

Orange Book

A202097

ABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Fentanyl Citrate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "UF599785JZ",
    "rxcui": "4337",
    "inchikey": "PJMPHNIQZUBGLI-UHFFFAOYSA-N",
    "display_name": "FENTANYL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "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": "47781-424_4b8493ea-0ce4-6949-e063-6294a90a8861",
  "productndc": "47781-424",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "202097",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MCG/HR",
        "product_no": "001",
        "approval_date": "Nov 4, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MCG/HR",
        "product_no": "002",
        "approval_date": "Nov 4, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MCG/HR",
        "product_no": "003",
        "approval_date": "Nov 4, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MCG/HR",
        "product_no": "004",
        "approval_date": "Nov 4, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MCG/HR",
        "product_no": "005",
        "approval_date": "Nov 4, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENTANYL",
  "shortage_reason": "Fentanyl Citrate Injection",
  "shortage_status": "current",
  "proprietary_name": "Fentanyl system",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA202097",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fentanyl",
  "start_marketing_date": "20161104",
  "active_numerator_strength": "25"
}

Related drugs

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