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United States · US · US:54288-117_7247d0b3-45ab-4da1-bf25-61e31a0960ff
EPINEPHRINE
In shortageOrange BookUNIISPLATC R03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBPI Labs, LLC
CountryUS (United States)
ATC codeR03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11542881171010 SYRINGE, GLASS in 1 CARTON (54288-117-10) / 1 mL in 1 SYRINGE, GLASS (54288-117-01)
Annotations
UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N205029
APAPAP
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": "54288-117_7247d0b3-45ab-4da1-bf25-61e31a0960ff",
"productndc": "54288-117",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "205029",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1MG/ML (1MG/ML)",
"product_no": "001",
"approval_date": "Jul 29, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "10MG/10ML (1MG/ML)",
"product_no": "002",
"approval_date": "Feb 4, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "003",
"approval_date": "May 12, 2023"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "30MG/30ML (1MG/ML)",
"product_no": "004",
"approval_date": "Feb 14, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG/ML (1MG/ML)",
"product_no": "005",
"approval_date": "Mar 4, 2024"
}
],
"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": "NDA205029",
"marketing_category": "NDA",
"nonproprietary_name": "EPINEPHRINE",
"start_marketing_date": "20230524",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R03AA01.
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