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United States · US · US:0517-3030_495f1aad-cf64-41ab-9f9e-59f6ebeb44aa

Epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0517303001
    1 VIAL in 1 CARTON (0517-3030-01) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
A217192
AP
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; 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": "0517-3030_495f1aad-cf64-41ab-9f9e-59f6ebeb44aa",
  "productndc": "0517-3030",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217192",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 30MG BASE/30ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 6, 2024"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA217192",
  "marketing_category": "ANDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20241009",
  "active_numerator_strength": "1"
}

Related drugs

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