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United States · US · US:82580-010_8c27cd52-6215-4cf8-98cc-f8816bf4c690

neffy

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

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

Packs · 1

  • ndc11
    8258001002
    2 BLISTER PACK in 1 CARTON (82580-010-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / 100 uL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N214697
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": "NASAL",
  "spl_meta": {
    "2052f9db-7d76-443b-b702-b6b499f9a4b8": {
      "match": "brand_token",
      "title": "NEFFY (EPINEPHRINE) SPRAY [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "82580-010_8c27cd52-6215-4cf8-98cc-f8816bf4c690",
  "productndc": "82580-010",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "214697",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/SPRAY",
        "product_no": "001",
        "approval_date": "Aug 9, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/SPRAY",
        "product_no": "002",
        "approval_date": "Mar 5, 2025"
      }
    ],
    "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": "neffy",
  "active_ingred_unit": "mg/100uL",
  "application_number": "NDA214697",
  "marketing_category": "NDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20250305",
  "active_numerator_strength": "1"
}

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