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United States · US · US:76420-835_1eb15488-8199-c343-e063-6394a90a0347

epinephrine

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7642083501
    1 CASE in 1 CARTON (76420-835-01) / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS
  • ndc11
    7642083502
    2 CASE in 1 CARTON (76420-835-02) / 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": "76420-835_1eb15488-8199-c343-e063-6394a90a0347",
  "productndc": "76420-835",
  "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",
  "active_ingred_unit": "mg/.15mL",
  "application_number": "NDA020800",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20100401",
  "active_numerator_strength": ".15"
}

Related drugs

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