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United States · US · US:0093-7866_4dbe9184-14cd-4666-aabf-1b7fece92337

Fentanyl Citrate

In shortageOrange BookUNIISPLATC N02AB03

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

Identification

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

Packs · 1

  • ndc11
    0093786665
    30 BLISTER PACK in 1 CARTON (0093-7866-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7866-19)

Annotations

UNII (FDA Substance ID)
MUN5LYG46H
FENTANYL CITRATE
RxCUI 142436
Orange Book
N020747
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": "ORAL; TRANSMUCOSAL",
  "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": "0093-7866_4dbe9184-14cd-4666-aabf-1b7fece92337",
  "productndc": "0093-7866",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "020747",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.2MG BASE",
        "product_no": "001",
        "approval_date": "Nov 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.4MG BASE",
        "product_no": "002",
        "approval_date": "Nov 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.6MG BASE",
        "product_no": "003",
        "approval_date": "Nov 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.8MG BASE",
        "product_no": "004",
        "approval_date": "Nov 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.2MG BASE",
        "product_no": "005",
        "approval_date": "Nov 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.6MG BASE",
        "product_no": "006",
        "approval_date": "Nov 4, 1998"
      }
    ],
    "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/1",
  "application_number": "NDA020747",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Fentanyl Citrate",
  "start_marketing_date": "20151208",
  "active_numerator_strength": "400"
}

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