Epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeR03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051822830
2 CONTAINER in 1 CARTON (70518-2283-0) / 1 SYRINGE in 1 CONTAINER / .3 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

YKH834O4BH

EPINEPHRINE

RxCUI 3992

Orange Book

A090589

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Epinephrine Bitartrate, Lidocaine Hydrochloride 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; 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": "70518-2283_49f0d87f-9010-9aa8-e063-6394a90aa3ce",
  "productndc": "70518-2283",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "090589",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG/DELIVERY",
        "product_no": "001",
        "approval_date": "Aug 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG/DELIVERY",
        "product_no": "002",
        "approval_date": "Aug 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Epinephrine",
  "active_ingred_unit": "mg/.3mL",
  "application_number": "ANDA090589",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Epinephrine",
  "start_marketing_date": "20190826",
  "active_numerator_strength": ".3"
}

Related drugs

Other records sharing ATC code R03AA01.

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