United States· US:63323-488_ea480a68-5927-4278-9deb-2956961da428
Xylocaine
A medicinal product containing lidocaine hydrochloride anhydrous; epinephrine bitartrate, registered in United States by Fresenius Kabi USA, LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1163323-488-17
- ndc1163323-488-31
- ndc1163323-488-37
- ndc11633234881725 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-488-01)
- ndc1163323488315 VIAL, SINGLE-DOSE in 1 CARTON (63323-488-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-03)
- ndc11633234883725 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-07)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Lidocaine hydrochloride anhydrous; epinephrine bitartrate in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomLidocaine 100mg/10ml (1%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoulesAguettant Ltd
- GermanyLidocain/Adrenalin AguettantLaboratoire Aguettant
- FinlandLidocain C AdrenalinOrion Corporation
- IrelandLidocaine/Adrenaline (Epinephrine) 10 mg/ml + 5 microgram/ml solution for injectionLaboratoire Aguettant
- SwitzerlandRapidocain 10 mg/ml con epinefrina 10 mcg/ml, soluzione iniettabileSintetica SA
- CanadaLIDO-2 LIQRAFTER 8 PRODUCTS INC
- PolandXylodont 2% z adrenaliną 1:100.000Molteni Dental s.r.l.
- SwedenLidokain/Adrenalin Aguettant 10 mg/ml + 5 mikrogram/ml Injektionsvätska, lösningLaboratoire Aguettant
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Lidokain/Adrenalin Aguettant, Xylanaest
- Belgium · Lidocaïne / Adrenaline Aguettant, Lidocaïne/Adrenaline Aguettant
- Bulgaria · Дилокаин
- Germany · Lidocain/Adrenalin Aguettant, Xylestesintm-A
- Denmark · Lidokain-Adrenalin Sad, Lidokain/Adrenalin Aguettant
- Spain · Lidocaína/Adrenalina Aguettant, Lidocaína/Adrenalina Normogen
- Finland · Lidocain C. Adrenalin Orion, Lidocain/Adrenalin Orion
- France · Lidocaine/Adrenaline Normon
- United Kingdom (Northern Ireland) · Eurocaine, Lidocaine With Adrenaline (Epinephrine) 1:200 000 Laboratoire Aguettant
- Greece · Lignospan
- Hungary · Lidocain-Adrenalin
- Ireland · Lidocaine/Adrenaline (Epinephrine) Laboratoire Aguettant, Lignospan Special
- Iceland · Lident, Lidokain/Adrenalin Aguettant
- Italy · Lidocaina E Adrenalina Aguettant, Xilo Mynol Adrenalina
- Luxembourg · Lidocaïne / Adrenaline Aguettant, Lidocaïne/Adrenaline Aguettant
- Netherlands · Lidocaïne/Adrenaline Aguettant, Lignospan Special
- Norway · Lidokain/Adrenalin Aguettant, Xylocain Dental
- Poland · Xylodont
- Portugal · Lidocaína + Adrenalina Normogen, Lidocaína + Adrenalina Normon
- Romania · Lident
- Sweden · Lidokain/Adrenalin Aguettant, Xylocain Dental
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/f7dcc30a-0515-4433-b979-ec5c9829a56d GET /v1/drugs/f7dcc30a-0515-4433-b979-ec5c9829a56d?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"source": "ndc",
"strength": "15; .005",
"substance": "LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE",
"productndc": "63323-488",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL; mg/mL",
"application_number": "NDA006488",
"marketing_category": "NDA"
}See everything about lidocaine hydrochloride anhydrous; epinephrine bitartrate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.