Epinephrine Pediatrics

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerSina Health Inc

CountryUS (United States)

ATC codeR03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7038520381
1 CASE in 1 PACKAGE (70385-2038-1) / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

YKH834O4BH

EPINEPHRINE

RxCUI 3992

Orange Book

N020800

BXBX

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": "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": "70385-2038_48354e20-6d6a-9faf-e063-6394a90ac1f2",
  "productndc": "70385-2038",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020800",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.3MG/DELIVERY",
        "product_no": "001",
        "approval_date": "May 30, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.15MG/DELIVERY",
        "product_no": "002",
        "approval_date": "May 28, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "BX",
        "strength": "EQ 0.15MG/DELIVERY",
        "product_no": "003",
        "approval_date": "Nov 25, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "BX",
        "strength": "EQ 0.3MG/DELIVERY",
        "product_no": "004",
        "approval_date": "Nov 25, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "Epinephrine Pediatrics",
  "active_ingred_unit": "mg/.15mL",
  "application_number": "NDA020800",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Epinephrine 0.15 Pediatrics",
  "start_marketing_date": "20100401",
  "active_numerator_strength": ".15"
}

Related drugs

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