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United States · US · US:0338-0024_74cb9596-3ecd-4d54-8a27-9dc270938aac

epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338002420
    20 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
30Q7KI53AK
EPINEPHRINE BITARTRATE
RxCUI 203180
Orange Book
N218475
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "30Q7KI53AK",
    "rxcui": "203180",
    "inchikey": "YLXIPWWIOISBDD-NDAAPVSOSA-N",
    "display_name": "EPINEPHRINE BITARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "0338-0024_74cb9596-3ecd-4d54-8a27-9dc270938aac",
  "productndc": "0338-0024",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218475",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Feb 28, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Mar 16, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE BITARTRATE",
  "shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "epinephrine",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA218475",
  "marketing_category": "NDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20250228",
  "active_numerator_strength": "64"
}

Related drugs

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