Fentanyl Citrate

In shortageOrange BookUNIISPLATC N02AB03

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeN02AB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6332380601
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11)
ndc11
6332380602
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12)
ndc11
6332380605
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13)
ndc11
6332380620
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14)
ndc11
6332380650
1 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

MUN5LYG46H

FENTANYL CITRATE

RxCUI 142436

Orange Book

A210762

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": "63323-806_341b092a-1f6f-40f1-98f2-9346bf2e1242",
  "productndc": "63323-806",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210762",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.05MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 3, 2019"
      }
    ],
    "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": "mg/mL",
  "application_number": "ANDA210762",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fentanyl Citrate",
  "start_marketing_date": "20190503",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code N02AB03.

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