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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
- ndc1182580010022 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"
}Related drugs
Other records sharing ATC code R03AA01.
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