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United States · US · US:50090-3039_f5379d23-2409-4aec-8ccb-0ee72a3f56a5

Epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009030391
    1 mL in 1 AMPULE (50090-3039-1)

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": "INTRAMUSCULAR; INTRAOCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "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": "50090-3039_f5379d23-2409-4aec-8ccb-0ee72a3f56a5",
  "productndc": "50090-3039",
  "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        "strength": "1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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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