FENTANYL

In shortageOrange BookUNIISPLATC N02AB03

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN02AB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378912598
5 POUCH in 1 CARTON (0378-9125-98) / 1 PATCH in 1 POUCH (0378-9125-16) / 72 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

UF599785JZ

FENTANYL

RxCUI 4337

Orange Book

A076258

ABABABABABABABAB

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": "0378-9125_a6e21c86-57e5-4be5-b1bb-c894893991b2",
  "productndc": "0378-9125",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "076258",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MCG/HR",
        "product_no": "001",
        "approval_date": "Jan 28, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MCG/HR",
        "product_no": "002",
        "approval_date": "Jan 28, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MCG/HR",
        "product_no": "003",
        "approval_date": "Jan 28, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MCG/HR",
        "product_no": "004",
        "approval_date": "Jan 28, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MCG/HR",
        "product_no": "005",
        "approval_date": "Jan 23, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MCG/HR",
        "product_no": "006",
        "approval_date": "Dec 29, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "62.5MCG/HR",
        "product_no": "007",
        "approval_date": "Dec 29, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "87.5MCG/HR",
        "product_no": "008",
        "approval_date": "Dec 29, 2014"
      }
    ],
    "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",
  "active_ingred_unit": "ug/h",
  "application_number": "ANDA076258",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FENTANYL",
  "start_marketing_date": "20150226",
  "active_numerator_strength": "37.5"
}

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