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United States · US · US:63323-698_4f83895f-638c-4515-af03-7c41ae60a42e
EPINEPHRINE
In shortageOrange BookUNIISPLATC R03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeR03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323698301 VIAL, MULTI-DOSE in 1 CARTON (63323-698-30) / 30 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N215425
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": "INTRAMUSCULAR; INTRAVENOUS; 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": "63323-698_4f83895f-638c-4515-af03-7c41ae60a42e",
"productndc": "63323-698",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "215425",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "30MG/30ML (1MG/ML)",
"product_no": "001",
"approval_date": "Mar 13, 2025"
}
],
"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/mL",
"application_number": "NDA215425",
"marketing_category": "NDA",
"nonproprietary_name": "EPINEPHRINE",
"start_marketing_date": "20250313",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R03AA01.
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