Epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

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
5009045430
2 CONTAINER in 1 CARTON (50090-4543-0) / 1 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

YKH834O4BH

EPINEPHRINE

RxCUI 3992

Orange Book

N019430

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",
  "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": "50090-4543_04793e78-0032-4331-84a2-ed3a160b88bd",
  "productndc": "50090-4543",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019430",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.3MG/DELIVERY",
        "product_no": "001",
        "approval_date": "Dec 22, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.15MG/DELIVERY",
        "product_no": "002",
        "approval_date": "Dec 22, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.3MG/DELIVERY",
        "product_no": "003",
        "approval_date": "Aug 3, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.15MG/DELIVERY",
        "product_no": "004",
        "approval_date": "Aug 3, 1995"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA019430",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Epinephrine",
  "start_marketing_date": "20161215",
  "active_numerator_strength": ".3"
}

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