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United States · US · US:80830-1659_fed06ffc-e17e-4809-ad5f-92e1a815c0aa
EPINEPHRINE
In shortageOrange BookUNIISPLATC R03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals Private Limited
CountryUS (United States)
ATC codeR03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11808301659225 VIAL, GLASS in 1 CARTON (80830-1659-2) / 1 mL in 1 VIAL, GLASS (80830-1659-1)
Annotations
UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
A218208
AP
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": "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": "80830-1659_fed06ffc-e17e-4809-ad5f-92e1a815c0aa",
"productndc": "80830-1659",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218208",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1MG BASE/ML (EQ 1MG BASE/ML)",
"product_no": "001",
"approval_date": "Dec 8, 2025"
}
],
"appl_type": "A"
},
"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": "ANDA218208",
"marketing_category": "ANDA",
"nonproprietary_name": "epinephrine",
"start_marketing_date": "20251208",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R03AA01.
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