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United States · US · US:71872-7117_eaeef79e-aef5-4321-e053-2a95a90acece

Epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerMedical Purchasing Solutions, LLC
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7187271171
    1 AMPULE in 1 BAG (71872-7117-1) / 1 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N205029
APAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "YKH834O4BH",
    "rxcui": "3992",
    "inchikey": "UCTWMZQNUQWSLP-VIFPVBQESA-N",
    "display_name": "EPINEPHRINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2099a4b3-66ca-4e01-a9e6-4790b538ec22": {
      "match": "brand_token",
      "title": "EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [CIVICA, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-11"
    }
  },
  "productid": "71872-7117_eaeef79e-aef5-4321-e053-2a95a90acece",
  "productndc": "71872-7117",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "205029",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 29, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 4, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "May 12, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "30MG/30ML (1MG/ML)",
        "product_no": "004",
        "approval_date": "Feb 14, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML (1MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 4, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "Epinephrine",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA205029",
  "marketing_category": "NDA",
  "nonproprietary_name": "Epinephrine",
  "start_marketing_date": "20140808",
  "active_numerator_strength": "1"
}

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