epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeR03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808368501
1 VIAL, MULTI-DOSE in 1 CARTON (68083-685-01) / 30 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

YKH834O4BH

EPINEPHRINE

RxCUI 3992

Orange Book

A219239

APAP

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": "68083-685_a7f9fba5-54b0-4001-ba9b-86468e159db7",
  "productndc": "68083-685",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219239",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 6, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/30ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 2, 2025"
      }
    ],
    "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": "ANDA219239",
  "marketing_category": "ANDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20251002",
  "active_numerator_strength": "1"
}

Related drugs

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