Epinephrine 0.15 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
7038520201
1 CONTAINER in 1 PACKAGE (70385-2020-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS

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": "70385-2020_48356318-9d53-131c-e063-6294a90a66c5",
  "productndc": "70385-2020",
  "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 0.15 Pediatrics",
  "active_ingred_unit": "mg/.3mL",
  "application_number": "NDA019430",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Epinephrine 0.15 Pediatrics",
  "start_marketing_date": "20161215",
  "active_numerator_strength": ".15"
}

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