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United States · US · US:70518-1342_48e8237a-ebac-db72-e063-6394a90a1f11

Adrenalin

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051813420
    25 VIAL in 1 CARTON (70518-1342-0) / 1 mL in 1 VIAL (70518-1342-1)

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N204200
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": {
    "a5ce0c01-dd47-4997-ab09-490de65d3835": {
      "match": "brand_token",
      "title": "ADRENALIN (EPINEPHRINE) INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "10",
      "published_date": "2026-04-22"
    }
  },
  "productid": "70518-1342_48e8237a-ebac-db72-e063-6394a90a1f11",
  "productndc": "70518-1342",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204200",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 7, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "Adrenalin",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA204200",
  "marketing_category": "NDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20180803",
  "active_numerator_strength": "1"
}

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