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United States · US · US:0338-0006_74cb9596-3ecd-4d54-8a27-9dc270938aac
epinephrine
In shortageOrange BookUNIISPLATC R03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeR03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11033800062020 BAG in 1 CARTON (0338-0006-20) / 250 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
30Q7KI53AK
EPINEPHRINE BITARTRATE
RxCUI 203180
Orange Book
N218475
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "30Q7KI53AK",
"rxcui": "203180",
"inchikey": "YLXIPWWIOISBDD-NDAAPVSOSA-N",
"display_name": "EPINEPHRINE BITARTRATE",
"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": "0338-0006_74cb9596-3ecd-4d54-8a27-9dc270938aac",
"productndc": "0338-0006",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218475",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)",
"product_no": "001",
"approval_date": "Feb 28, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)",
"product_no": "002",
"approval_date": "Mar 16, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPINEPHRINE BITARTRATE",
"shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "epinephrine",
"active_ingred_unit": "ug/mL",
"application_number": "NDA218475",
"marketing_category": "NDA",
"nonproprietary_name": "epinephrine",
"start_marketing_date": "20260316",
"active_numerator_strength": "16"
}Related drugs
Other records sharing ATC code R03AA01.
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