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United States · US · US:51662-1531_1032c441-4e3d-930a-e063-6394a90a5f35

EPINEPHRINE

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeR03AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166215311
    1 SYRINGE, GLASS in 1 CARTON (51662-1531-1) / 10 mL in 1 SYRINGE, GLASS
  • ndc11
    5166215313
    50 POUCH in 1 CARTON (51662-1531-3) / 1 CARTON in 1 POUCH (51662-1531-2) / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N209359
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": "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": "51662-1531_1032c441-4e3d-930a-e063-6394a90a5f35",
  "productndc": "51662-1531",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209359",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/10ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 5, 2019"
      }
    ],
    "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/mL",
  "application_number": "NDA209359",
  "marketing_category": "NDA",
  "nonproprietary_name": "EPINEPHRINE",
  "start_marketing_date": "20210425",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code R03AA01.

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